Neurology — Therapeutic Area Intelligence | Humanexa Signals

ClinicalAugust 5, 2026

Rimegepant Study in Adolescents with Frequent Migraine Begins Enrollment

A clinical trial is underway to evaluate the safety and efficacy of rimegepant in adolescents suffering from frequent migraines.

ClinicalAugust 5, 2026

KarXT Study for Bipolar-I Disorder Mania Shows Potential Efficacy

A study is underway to assess the efficacy and safety of adjunctive KarXT in treating mania in Bipolar-I Disorder patients.

RegulatoryAugust 5, 2026

FDA Grants AP Status for Carbamazepine ANDA207798 by UMEDICA

The FDA has granted Abbreviated Approval (AP) status for UMEDICA's ANDA207798 for Carbamazepine.

StrategyAugust 5, 2026

Teva's Gabapentin ANDA075435 Receives AP Status from FDA

Teva Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Gabapentin.

ClinicalAugust 5, 2026

HI-tACS Trial Aims to Improve Executive Control in Gambling Disorder Patients

A randomized controlled trial is assessing the efficacy of high-intensity transcranial alternating current stimulation on executive-control functions in gambling disorder patients.

ClinicalAugust 5, 2026

MSC-Exosome Therapy Shows Promise for Frontotemporal Dementia Treatment

A study is underway testing MSC-Exosome therapy for Frontotemporal Dementia, a disease with no current cure.

RegulatoryAugust 4, 2026

FDA Grants AP Status for Acetazolamide Sodium ANDA200880

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Acetazolamide Sodium submitted by Mylan ASI.

CompetitiveAugust 4, 2026

iVEAcare Neuromodulation System Study for Drug-Resistant Epilepsy Underway

A feasibility study is assessing the safety and performance of the iVEAcare Neuromodulation System in drug-resistant epilepsy patients.

ClinicalAugust 4, 2026

Study on Transcranial Pulse Stimulation for Alzheimer's Disease Safety and Efficacy

The study aims to assess the safety and effects of Transcranial Pulse Wave Stimulation in Alzheimer's patients.

CompetitiveAugust 4, 2026

ALKS 2680 Shows Promise in Reducing Sleepiness and Cataplexy in Narcolepsy Type 1

A study is underway to evaluate the safety and effectiveness of ALKS 2680 in patients with Narcolepsy Type 1.

ClinicalAugust 4, 2026

QIVIGY Study Initiated for Stiff Person Syndrome Efficacy and Safety

A clinical trial is underway to assess the efficacy and safety of QIVIGY in adults with stiff person syndrome compared to placebo.

ClinicalAugust 4, 2026

Phase I Trial of High-Density Theta Burst Stimulation (hdTBS) Initiated

A Phase I trial is underway to evaluate the safety and efficacy of high-density theta burst stimulation (hdTBS) in healthy adults.

RegulatoryAugust 3, 2026

FDA Approves Lamotrigine Supplement Application by Taro

The FDA has approved a supplemental application for lamotrigine submitted by Taro.

RegulatoryAugust 3, 2026

FDA Grants Approval for Valproic Acid Supplement by Sun Pharma

The FDA has granted approval for the supplemental application ANDA091037 for Valproic Acid submitted by Sun Pharma.

StrategyAugust 3, 2026

FDA Grants Approval for Bupropion Hydrochloride by Yichang Humanwell

The FDA has granted approval for the ANDA220529 application for Bupropion Hydrochloride submitted by Yichang Humanwell.

RegulatoryAugust 3, 2026

FDA Grants Approval for Gabapentin Supplement by Zhejiang Yongtai

The FDA has granted approval for a supplemental application for Gabapentin submitted by Zhejiang Yongtai.

ClinicalAugust 3, 2026

Exploratory Study of UX-DA001 in Parkinson's Disease Shows Potential for Motor Function Improvement

The study aims to assess the safety, tolerability, and efficacy of UX-DA001 in improving motor function in Parkinson's disease patients.

StrategyAugust 3, 2026

Teva's Gabapentin ANDA205807 Receives AP Status from FDA

Teva Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval for Gabapentin.

RegulatoryAugust 3, 2026

FDA Approves Supplement for Deutetrabenazine by Aurobindo Pharma

The FDA has approved a supplemental application for deutetrabenazine submitted by Aurobindo Pharma.

RegulatoryAugust 2, 2026

FDA Grants AP Status for Lamotrigine ANDA078982 by Granules

The FDA has granted approval status (AP) for the ANDA078982 application for Lamotrigine submitted by Granules.

ClinicalAugust 2, 2026

Eptinezumab shows promise for migraine prevention in new study

A multicentric study is underway to assess the effectiveness and tolerability of eptinezumab for migraine prevention.

RegulatoryAugust 2, 2026

FDA Approves Pregabalin Application ANDA219593 by Unichem

The FDA has approved the ANDA219593 application for Pregabalin submitted by Unichem.

RegulatoryAugust 2, 2026

FDA Submission Update for AXSOME's AUVELITY (NDA215430)

The FDA has received a supplemental application (NDA215430) for AUVELITY from AXSOME, with a standard review priority.

RegulatoryAugust 2, 2026

FDA Accepts Supplemental NDA for REXULTI (Brexpiprazole)

The FDA has accepted a supplemental NDA for REXULTI, indicating ongoing development and potential label expansion.

RegulatoryAugust 2, 2026

FDA Approves QLONILIK (Clonidine Hydrochloride) NDA221094

The FDA has approved QLONILIK, containing Clonidine Hydrochloride, under NDA221094.

RegulatoryAugust 2, 2026

FDA Acceptance of Lacosamide Supplement by MSN Labs

The FDA has accepted a supplemental application for Lacosamide submitted by MSN Labs.

RegulatoryAugust 1, 2026

Baxter Healthcare's Diazepam ANDA219882 Receives Approval Status

Baxter Healthcare Corporation's ANDA219882 for Diazepam has received an approval status of AP.

RegulatoryAugust 1, 2026

FDA Approves Supplement for HETLIOZ (Tasimelteon) by Vanda Pharmaceuticals

The FDA has approved a supplemental application for HETLIOZ, a drug containing tasimelteon.

RegulatoryAugust 1, 2026

FDA Approves Supplement for Methylphenidate by Mylan Tech Viatris

The FDA has approved a supplemental application for Methylphenidate submitted by Mylan Tech Viatris.

RegulatoryAugust 1, 2026

FDA Approval Process Update for OXCARBAZEPINE by UMEDICA LABS

UMEDICA LABS has submitted an original application for OXCARBAZEPINE, currently under standard review.

RegulatoryAugust 1, 2026

FDA Approval Process Update for Methylphenidate Hydrochloride by Rising

The FDA has accepted the supplemental application ANDA205756 for Methylphenidate Hydrochloride submitted by Rising.

RegulatoryJuly 31, 2026

FDA Approval Status Update for Carbamazepine ANDA205571 by Zydus Pharmaceuticals

The FDA has granted an approval status of 'AP' for ANDA205571, a supplemental application for Carbamazepine by Zydus Pharmaceuticals.

RegulatoryJuly 31, 2026

Aurobindo Pharma submits original application for Cenobamate

Aurobindo Pharma has submitted an original application for Cenobamate under ANDA219473, currently under standard review.

RegulatoryJuly 31, 2026

FDA Approval Process Update for Gabapentin ANDA214957

The FDA is reviewing ANDA214957 for Gabapentin submitted by Ascent Pharms Inc. under standard review priority.

ClinicalJuly 31, 2026

Study on IVIG for Neurological Symptoms in Long COVID Patients

A clinical trial is investigating the efficacy of human immunoglobulin (IVIG) in treating neurological symptoms associated with Long COVID.

ClinicalJuly 31, 2026

Study Evaluates Anterior Carpal Ligament Biopsy for Early Detection of ATTR

The study compares the diagnostic concordance of anterior carpal ligament biopsy to the gold standard synovial biopsy for ATTR.

RegulatoryJuly 31, 2026

FDA Grants Abbreviated Approval for Dextroamphetamine Combination Products

The FDA has granted abbreviated approval for ANDA211547, a combination of dextroamphetamine and amphetamine salts.

RegulatoryJuly 31, 2026

FDA Approves Doxepin Hydrochloride Application by Sun Pharma

The FDA has approved the application ANDA213919 for Doxepin Hydrochloride submitted by Sun Pharma.

ClinicalJuly 31, 2026

Trial on TMS for Early Alzheimer's Disease Shows Potential Efficacy

The trial aims to evaluate the safety and efficacy of personalized neuronavigated TMS in early Alzheimer's disease patients.

RegulatoryJuly 31, 2026

FDA Grants Priority Review for NUPLAZID Supplement NDA210793

The FDA has granted priority review status for the supplemental NDA for NUPLAZID, an indication for pimavanserin tartrate.

RegulatoryJuly 31, 2026

FDA grants priority review for NUPLAZID supplemental application

The FDA has granted priority review status for the supplemental application of NUPLAZID (pimavanserin tartrate) submitted by ACADIA Pharmaceuticals.

ClinicalJuly 31, 2026

Virtual Reality for Cognitive Remediation in Elderly Patients with Depression

A study is investigating the acceptability of virtual reality as a cognitive remediation tool for elderly patients with depression.

ClinicalJuly 30, 2026

Study on Focused Ultrasound for Recovery After Severe Brain Injury Initiated

A clinical trial is underway to assess the efficacy of low-intensity focused ultrasound in patients with disorders of consciousness following severe brain injury.

StrategyJuly 30, 2026

FDA Approves Lamotrigine ANDA206382 Submission by Sciegen Pharmaceuticals

The FDA has accepted the Abbreviated New Drug Application (ANDA) for lamotrigine submitted by Sciegen Pharmaceuticals.

RegulatoryJuly 30, 2026

Lupin's Diazepam ANDA220365 Receives Approval Status from FDA

Lupin's ANDA for Diazepam has received an approval status (AP) from the FDA.

ClinicalJuly 30, 2026

Study on rTMS for PTSD in Veterans Aims to Understand Mechanisms of Action

The study investigates the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on PTSD symptoms in veterans, focusing on brain function and inflammation.

RegulatoryJuly 30, 2026

FDA Grants Priority Review for Otsuka's Simtriyo (Centanafadine)

The FDA has granted priority review status for Otsuka Pharmaceutical's NDA for Simtriyo, containing centanafadine.

StrategyJuly 30, 2026

FDA Grants Approval for Biocon's Topiramate ANDA220943

The FDA has granted approval for Biocon Pharma's Abbreviated New Drug Application (ANDA) for Topiramate.

StrategyJuly 30, 2026

FDA Approves Fingolimod Hydrochloride Application by Alembic

The FDA has granted approval for the ANDA207974 application for Fingolimod Hydrochloride submitted by Alembic.

StrategyJuly 29, 2026

FDA Grants Approval for Gabapentin ANDA214956 by Ascent Pharm Inc.

The FDA has granted approval for ANDA214956, a supplemental application for Gabapentin submitted by Ascent Pharm Inc.

RegulatoryJuly 29, 2026

FDA Accepts Supplemental NDA for CAPLYTA (Lumateperone Tosylate)

The FDA has accepted a supplemental NDA for CAPLYTA, indicating progress in its regulatory review.

StrategyJuly 29, 2026

FDA Grants AP Status for Topiramate ANDA079162 by Invagen Pharmaceuticals

The FDA has granted Abbreviated Approval (AP) status for the ANDA079162 application for Topiramate submitted by Invagen Pharmaceuticals.

ClinicalJuly 29, 2026

Web-based CBT for Insomnia in Dementia Caregivers: A New Study Launch

A new study is testing a web-based cognitive behavioral therapy for insomnia (WebCBT-I) tailored for dementia caregivers.

RegulatoryJuly 29, 2026

FDA Grants Priority Review for Otsuka's Simtriyo (Centanafadine)

The FDA has granted priority review status for Otsuka's NDA for Simtriyo, an ADHD treatment containing centanafadine.

ClinicalJuly 29, 2026

Trial Initiated for CBD Effects on Alzheimer's Disease Biomarkers

A double-blind, randomized controlled trial is underway to evaluate the effects of CBD on Alzheimer's disease biomarkers and clinical measures.

RegulatoryJuly 29, 2026

FDA Accepts Supplemental Application for TYRUKO (Natalizumab-SZTN)

The FDA has accepted a supplemental application for TYRUKO, a biosimilar of natalizumab.

StrategyJuly 29, 2026

FDA Grants Approval for Zydus' Edaravone ANDA218349

The FDA has granted approval for Zydus Pharmaceuticals' Abbreviated New Drug Application for Edaravone.

RegulatoryJuly 29, 2026

FDA Accepts Supplemental NDA for NEURACEQ by Lantheus

The FDA has accepted a supplemental NDA for NEURACEQ, an imaging agent containing Florbetaben F-18.

StrategyJuly 29, 2026

FDA Grants AP Status for Aurobindo's Bupropion Hydrochloride

The FDA has granted Aurobindo Pharma's application for Bupropion Hydrochloride an Abbreviated New Drug Application (ANDA) status.

RegulatoryJuly 29, 2026

FDA Accepts Supplemental Application for ZYBAN by GlaxoSmithKline

The FDA has accepted a supplemental application for ZYBAN, an established smoking cessation aid.

RegulatoryJuly 29, 2026

FDA Accepts Supplement for Vyvanse (NDA 208510) from Takeda

The FDA has accepted a supplemental application for Vyvanse (lisdexamfetamine dimesylate) from Takeda Pharmaceuticals.

RegulatoryJuly 29, 2026

FDA Accepts Supplemental Application for Vyvanse by Takeda

The FDA has accepted a supplemental application for Vyvanse (lisdexamfetamine dimesylate) submitted by Takeda Pharmaceuticals.

RegulatoryJuly 29, 2026

FDA Submission Update for Adderall XR 10 by Takeda

Takeda Pharmaceuticals has submitted a supplemental application for Adderall XR 10 (NDA021303) with a standard review priority.

RegulatoryJuly 28, 2026

FDA Accepts Supplement for MYDAYIS by Takeda

The FDA has accepted a supplemental application for MYDAYIS, a medication for ADHD, from Takeda Pharmaceuticals.

RegulatoryJuly 28, 2026

Impax Labs receives FDA approval for Methylphenidate Hydrochloride supplement

Impax Labs has received an Abbreviated New Drug Application (ANDA) approval for a supplement related to Methylphenidate Hydrochloride.

RegulatoryJuly 28, 2026

FDA Grants AP Status for Levetiracetam Supplement by Strides Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for a supplement of levetiracetam submitted by Strides Pharma.

RegulatoryJuly 28, 2026

FDA Accepts Supplement for Dalfampridine by Accord Healthcare

The FDA has accepted a supplemental application for Dalfampridine submitted by Accord Healthcare.

ClinicalJuly 28, 2026

Study on Physical Activity's Impact on Self-esteem in Alzheimer's Patients

A study is evaluating the effectiveness of adapted physical activity on self-esteem and motivation in older adults with cognitive disorders, including Alzheimer's.

ClinicalJuly 28, 2026

Takeda's TAK-360 Trial for Narcolepsy Type 1 Underway

Takeda is conducting a clinical trial to evaluate the safety and tolerability of TAK-360 in adults with Narcolepsy Type 1.

RegulatoryJuly 28, 2026

FDA Accepts Supplemental NDA for Biogen's Zuranolone (ZURZUVAE)

The FDA has accepted a supplemental NDA for Biogen's Zuranolone, indicating progress in its regulatory pathway.

RegulatoryJuly 28, 2026

FDA Grants AP Status for Carbamazepine ANDA219072 by Yichang Humanwell

The FDA has granted approval status (AP) for the ANDA219072 application for Carbamazepine submitted by Yichang Humanwell.

RegulatoryJuly 28, 2026

FDA Accepts Lamotrigine Supplement Application from Glenmark

The FDA has accepted a supplemental application for Lamotrigine from Glenmark Pharmaceuticals.

RegulatoryJuly 27, 2026

FDA Approves Supplement for Valproic Acid by Quagen

The FDA has approved a supplemental application for Valproic Acid submitted by Quagen.

RegulatoryJuly 27, 2026

FDA Accepts Supplemental Application for Diacomit (Stiripentol)

The FDA has accepted a supplemental application for Diacomit (stiripentol) submitted by Biocodex SA.

ClinicalJuly 27, 2026

Phase II Study Links Chronic Hypoxia to Multiple System Atrophy Risk in Han Chinese

The High-Altitude Neurodegeneration Cohort study aims to validate the link between chronic hypoxia and multiple system atrophy (MSA) risk in a large cohort of Han Chinese participants.

ClinicalJuly 27, 2026

Study on Interdisciplinary Program to Enhance Quality of Life in Fibromyalgia Patients

A quasi-experimental study is evaluating the effectiveness of a multidisciplinary program for fibromyalgia patients in Spain.

ClinicalJuly 27, 2026

Ravulizumab Study in Chinese Adults with Generalized Myasthenia Gravis Initiated by Alexion

A clinical trial is underway to assess the efficacy and safety of ravulizumab in Chinese adults with generalized myasthenia gravis.

ClinicalJuly 27, 2026

UCB Biopharma's Staccato Alprazolam Trial Targets Prolonged Seizures in Patients 12 and Older

A study is underway to evaluate the efficacy and safety of Staccato alprazolam in terminating seizure episodes in patients aged 12 and older.

RegulatoryJuly 27, 2026

FDA Submission Update for Buspirone Hydrochloride by Oxford Pharms

The FDA has received a supplemental application for Buspirone Hydrochloride (ANDA075388) from Oxford Pharms.

ClinicalJuly 27, 2026

Medtronic's Percept PC DBS Study for Treatment Resistant Depression Initiated

A new study is investigating the use of Medtronic's Percept PC deep brain stimulation device for treatment resistant depression, focusing on local field potentials.

ClinicalJuly 27, 2026

Low-Level Infrared Light Therapy Shows Promise for Autism Spectrum Disorder

A study is investigating the effects of low-level infrared light therapy on cognitive and emotional improvements in individuals with autism spectrum disorder.

RegulatoryJuly 26, 2026

FDA Accepts Supplemental NDA for Diacomit (Stiripentol) by Biocodex

The FDA has accepted a supplemental NDA for Diacomit, an epilepsy treatment containing stiripentol.

RegulatoryJuly 26, 2026

FDA Accepts Supplement for DATSCAN (NDA022454) by GE Healthcare

The FDA has accepted a supplemental application for DATSCAN (NDA022454) from GE Healthcare.

RegulatoryJuly 26, 2026

AstraZeneca's EPLONTERSEN SODIUM Autoinjector Receives AP Status from FDA

The FDA has granted an Approval Pending (AP) status for AstraZeneca's autoinjector application for EPLONTERSEN SODIUM.

CompetitiveJuly 26, 2026

B2227 vs. Vraylar: Pharmacokinetics Study in Schizophrenia Launched

A new study has been initiated to compare the pharmacokinetics of B2227 Extended-Release Injectable Suspension with Vraylar® in schizophrenia patients.

RegulatoryJuly 26, 2026

FDA Approves Supplemental Application for Milnacipran Hydrochloride

The FDA has approved a supplemental application for Milnacipran Hydrochloride submitted by Breckenridge.

StrategyJuly 26, 2026

FDA Grants AP Status for Milnacipran Hydrochloride by Amneal Pharmaceuticals

The FDA has granted Abbreviated Approval (AP) status for Milnacipran Hydrochloride submitted by Amneal Pharmaceuticals.

RegulatoryJuly 26, 2026

FDA Approval Process Update for Lamotrigine by Alembic Pharmaceuticals

Alembic Pharmaceuticals has submitted a supplemental application for Lamotrigine, currently under standard review.

RegulatoryJuly 26, 2026

FDA Accepts Supplemental Application for SPRAVATO (Esketamine)

The FDA has accepted a supplemental application for SPRAVATO, an esketamine-based treatment.

StrategyJuly 26, 2026

FDA Approves Pimozide Application ANDA219897 from Novitium Pharma

The FDA has approved the application ANDA219897 for Pimozide submitted by Novitium Pharma.

StrategyJuly 26, 2026

FDA Grants AP Status for Lamotrigine ANDA078947 by Torrent Pharmaceuticals

The FDA has granted Abbreviated Approval (AP) status for Torrent Pharmaceuticals' ANDA078947 for Lamotrigine.

RegulatoryJuly 26, 2026

FDA Accepts Supplemental NDA for Concerta by Janssen Pharmaceuticals

The FDA has accepted a supplemental NDA for Concerta, a medication containing methylphenidate hydrochloride, submitted by Janssen Pharmaceuticals.

ClinicalJuly 26, 2026

Study on Predictors of Drug-Resistant Epilepsy in Children Initiated

A prospective cohort study is underway to identify predictors of drug-resistant epilepsy in children using machine-learning models.

ClinicalJuly 25, 2026

Eisai Initiates Study on Algorithms for Intracerebral Hemorrhage and Seizures in Alzheimer's Disease

Eisai Inc. is conducting a retrospective study to develop algorithms for identifying intracerebral hemorrhage and new-onset seizures in Alzheimer's patients using claims data linked to electronic health records.

StrategyJuly 25, 2026

FDA Grants Approval for Methylphenidate Hydrochloride ANDA206932

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for Methylphenidate Hydrochloride submitted by ABHAI LLC.

RegulatoryJuly 25, 2026

FDA Grants AP Status for Gabapentin ANDA217995 by Rising

The FDA has granted approval status (AP) for ANDA217995, a supplemental application for Gabapentin submitted by Rising.

StrategyJuly 25, 2026

Novel PLC-SNEDDS Enhances Oral Bioavailability of Cannabidiol Significantly

A new phospholipid complex self-nanoemulsifying drug delivery system (CBD-PLC-SNEDDS) significantly enhances the oral bioavailability of cannabidiol to 92%.

RegulatoryJuly 25, 2026

Aurobindo Pharma's Bupropion Hydrochloride ANDA216051 Receives AP Status

Aurobindo Pharma's ANDA216051 for Bupropion Hydrochloride has received Abbreviated Approval (AP) status from the FDA.

ClinicalJuly 25, 2026

Neurophysiological Study on DBS in OCD Patients to Inform Neuromodulation Strategies

A clinical trial is underway to investigate the neurophysiological mechanisms in OCD patients using deep brain stimulation (DBS) with Medtronic's technology.

ClinicalJuly 25, 2026

Avidity Biosciences initiates Phase 3 study for Del-desiran in Myotonic Dystrophy Type 1

Avidity Biosciences has launched Phase 3 open-label extension study for Del-desiran, focusing on long-term safety and efficacy.

RegulatoryJuly 25, 2026

FDA Accepts Supplemental NDA for Subvenite (Lamotrigine) by OWP Pharms

The FDA has accepted a supplemental NDA for Subvenite, which contains lamotrigine as the active ingredient.

RegulatoryJuly 25, 2026

FDA Accepts Supplement Application for Gabapentin by Zydus Pharmaceuticals

The FDA has accepted a supplemental application for gabapentin submitted by Zydus Pharmaceuticals.

StrategyJuly 25, 2026

FDA Accepts Pregabalin ANDA211687 Submission from Alvogen

The FDA has accepted Alvogen's Abbreviated New Drug Application for Pregabalin, indicating a step towards potential market entry.

StrategyJuly 24, 2026

FDA Grants Approval for Pitolisant Hydrochloride by Novitium Pharma

The FDA has granted approval for Pitolisant Hydrochloride under ANDA218495 submitted by Novitium Pharma.

ClinicalJuly 24, 2026

Phase 1/2 Study of TSHA-105 in SLC13A5 Citrate Transporter Disorder Initiated

A Phase 1/2 open-label study is underway to evaluate TSHA-105 for SLC13A5 Citrate Transporter Disorder.

RegulatoryJuly 24, 2026

FDA Submission Status Update for Edaravone by Azurity Pharmaceuticals

Azurity Pharmaceuticals has submitted New Drug Application (NDA) for Edaravone under application number NDA221059.

ClinicalJuly 24, 2026

Traditional Chinese Medicine Shows Promise in Treating Cerebral Ischemia-Reperfusion Injury

Traditional Chinese medicine (TCM) demonstrates potential advantages in managing cerebral ischemia-reperfusion injury (CIRI) through its multi-target approach.

RegulatoryJuly 24, 2026

FDA Acceptance of Ubrogepant Application by MSN Laboratories

The FDA has accepted the application for Ubrogepant submitted by MSN Laboratories.

RegulatoryJuly 24, 2026

FDA Accepts ANDA for Desvenlafaxine Succinate by Platinum

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Desvenlafaxine Succinate submitted by Platinum.

RegulatoryJuly 24, 2026

Hikma's Lisdexamfetamine Dimesylate Supplement Receives FDA Acceptance

The FDA has accepted Hikma's supplemental application for Lisdexamfetamine Dimesylate.

ClinicalJuly 23, 2026

RECONNECT Study Evaluates Deep Brain Stimulation for Chronic Disorders of Consciousness

The RECONNECT study is assessing the safety and efficacy of deep brain stimulation in patients with chronic disorders of consciousness.

ClinicalJuly 23, 2026

Red-light therapy trial for Dementia with Lewy Bodies shows potential for cognitive and quality of life improvements

A clinical trial is evaluating red-light therapy's effects on symptoms and quality of life in patients with Dementia with Lewy Bodies.

StrategyJuly 23, 2026

Sandoz's Gabapentin ANDA075428 Receives Abbreviated Approval

Sandoz has received an abbreviated approval for its ANDA075428 application for Gabapentin.

RegulatoryJuly 23, 2026

FDA Approval Update for Acetazolamide Supplement by Heritage Pharma

Heritage Pharma has received an approval update for a supplement application for Acetazolamide.

RegulatoryJuly 23, 2026

FDA Accepts Pregabalin Supplement Application ANDA209357 from MSN

The FDA has accepted a supplemental application for Pregabalin (ANDA209357) from sponsor MSN.

RegulatoryJuly 23, 2026

FDA Approves Supplemental Applications for ZYBAN by GlaxoSmithKline

The FDA has approved supplemental applications for ZYBAN (bupropion hydrochloride) submitted by GlaxoSmithKline.

RegulatoryJuly 23, 2026

FDA Grants Priority Review for LEQEMBI Supplement Application

The FDA has granted priority review status for the supplemental application of LEQEMBI (lecanemab-IRMB) submitted by Eisai Inc.

RegulatoryJuly 22, 2026

FDA Accepts Supplement for Oxcarbazepine ANDA215332

The FDA has accepted a supplemental application for oxcarbazepine under ANDA215332 from sponsor AUCTA.

ClinicalJuly 22, 2026

Study on rTMS and Olfactory Training for Parkinson's Disease Shows Promise

A clinical trial is evaluating the efficacy of rTMS combined with olfactory training in Parkinson's patients to restore chemosensory function.

ClinicalJuly 22, 2026

Study Evaluates Biomarkers for Niemann-Pick Disease, Type C Progression

A clinical study is underway to identify biomarkers for Niemann-Pick Disease, Type C, which may aid in treatment response assessment.

ClinicalJuly 22, 2026

Alexion's Ravulizumab Shows Promise in Pediatric NMOSD Study

A clinical trial is underway to assess the safety and efficacy of ravulizumab in children with NMOSD.

StrategyJuly 22, 2026

VIVACITY-MG3 Study Reveals High Healthcare Costs in Generalized Myasthenia Gravis Patients Treated with Nipocalimab

The VIVACITY-MG3 study highlights significant healthcare resource utilization and economic burden in adults with generalized myasthenia gravis treated with nipocalimab.

RegulatoryJuly 22, 2026

FDA Accepts Supplement for Diazepam by Hikma

The FDA has accepted a supplemental application for Diazepam submitted by Hikma.

ClinicalJuly 22, 2026

Peer Support Study Aims to Enhance Adherence in MS Patients

A pilot study is underway to evaluate the effect of peer support on therapeutic adherence in patients with relapsing-remitting multiple sclerosis.

ClinicalJuly 22, 2026

Phase I Trial of Pembrolizumab for Neurological Symptoms Post-COVID-19

A Phase I open-label trial is underway to evaluate the safety of pembrolizumab in patients with neurological symptoms following COVID-19.

RegulatoryJuly 21, 2026

FDA Grants Approval for OXCARBAZEPINE ANDA209020

The FDA has granted approval for the ANDA209020 application for OXCARBAZEPINE submitted by MSN.

RegulatoryJuly 21, 2026

FDA Approval Update for OXCARBAZEPINE by Glenmark Pharmaceuticals

The FDA has accepted the supplemental application for OXCARBAZEPINE submitted by Glenmark Pharmaceuticals.

RegulatoryJuly 21, 2026

FDA Grants AP Status for Carbidope and Levodopa Supplement by Rubicon Research

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for a supplement involving Carbidope and Levodopa by Rubicon Research.

RegulatoryJuly 21, 2026

Lupin's Divalproex Sodium Supplement Receives FDA AP Status

Lupin's application for Divalproex Sodium has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryJuly 21, 2026

FDA Accepts Supplement for OXCARBAZEPINE by Annora Pharma

The FDA has accepted a supplemental application for OXCARBAZEPINE submitted by Annora Pharma.

ClinicalJuly 21, 2026

Study on Dopamine Release in Cocaine Use Disorders Using PET Imaging

This study investigates dopamine release in cocaine use disorders using PET imaging with amphetamine challenges.

RegulatoryJuly 21, 2026

Manufacturing Issue with Xaggitin XL Tablets Reported by Martindale Pharma

A manufacturing defect has been reported for Xaggitin XL Prolonged-release Tablets, affecting tablet counts in multiple batches.

RegulatoryJuly 21, 2026

Impax Labs Receives AP Status for Carbidope and Levodopa Supplement

Impax Labs has received an Abbreviated Approval (AP) for a supplement application of Carbidope and Levodopa.

StrategyJuly 21, 2026

FDA Grants AP Status for Zydus' Oxcarbazepine ANDA211747

The FDA has granted Abbreviated Approval (AP) status for Zydus' ANDA211747 for oxcarbazepine.

RegulatoryJuly 21, 2026

Apotex submits supplemental ANDA for Carbidopa and Levodopa

Apotex Inc. has submitted a supplemental abbreviated new drug application (ANDA077120) for Carbidopa and Levodopa.

ClinicalJuly 21, 2026

Hoffmann-La Roche's Prasinezumab Trial Targets Early-Stage Parkinson's Disease

A clinical trial is underway to assess the efficacy and safety of intravenous prasinezumab in early-stage Parkinson's disease patients.

ClinicalJuly 20, 2026

Aquatic HIIT Trial for Parkinson's Disease Shows Potential Benefits

A randomized trial is assessing the impact of an 8-week aquatic HIIT program on patients with Parkinson's disease.

ClinicalJuly 20, 2026

Study on Sleep Intervention's Impact on Alzheimer's Disease Progression

A study is investigating the effects of time-in-bed restriction on sleep quality and cognitive function in older adults at risk for Alzheimer's disease.

ClinicalJuly 20, 2026

Study on Stent-assisted Coil Embolization for Acute Intracranial Aneurysms

The study evaluates the safety and efficacy of stent-assisted coil embolization in treating acute ruptured intracranial aneurysms.

StrategyJuly 20, 2026

FDA Grants Approval for Topiramate ANDA220041 by Riconpharma

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 220041 for Topiramate submitted by Riconpharma.

ClinicalJuly 20, 2026

Merck's MK-2214 Trial Aims to Slow Tau Spread in Early Alzheimer's Disease

Merck is conducting a clinical trial to evaluate the efficacy and safety of MK-2214 in slowing tau protein accumulation in early Alzheimer's disease patients.

StrategyJuly 20, 2026

Aurobindo Pharma's Lacosamide ANDA209224 Receives AP Status from FDA

The FDA has granted Aurobindo Pharma's ANDA209224 for Lacosamide an Abbreviated Approval (AP) status.

StrategyJuly 20, 2026

Aurobindo Pharma's Lacosamide ANDA204994 Receives AP Status from FDA

Aurobindo Pharma's application for Lacosamide (ANDA204994) has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryJuly 20, 2026

FDA Accepts Supplement for FINTEPLA (Fenfluramine) by UCB

The FDA has accepted a supplemental application for FINTEPLA, an epilepsy treatment containing fenfluramine hydrochloride.

ClinicalJuly 20, 2026

Trial on Intra-Arterial Cooling Infusion in Acute Ischemic Stroke Initiated

A multicenter trial is evaluating the safety and efficacy of selective intra-arterial cooling infusion combined with EVT in acute ischemic stroke.

ClinicalJuly 20, 2026

Study Identifies Key Genes and Potential Therapies in Myasthenia Gravis via Lipid Metabolism Regulation

The study identified IRS2 and ALDH2 as key genes linked to lipid metabolism dysregulation in myasthenia gravis, with potential therapeutic candidates including metformin and cyclophosphamide.

ClinicalJuly 20, 2026

Gut microbiota dynamics linked to opioid use disorder in mouse model

The study reveals that morphine-induced gut microbiota dysbiosis may contribute to compulsive drug-seeking behavior in mice, with significant differences in microbiota stability between compulsive and non-compulsive subjects.

StrategyJuly 20, 2026

FDA Approves ANDA for Lacosamide by Steranco Healthcare

The FDA has granted approval for ANDA220366, a generic version of lacosamide, submitted by Steranco Healthcare.

StrategyJuly 19, 2026

FDA Approves Clonazepam ANDA216988 from Rubicon Research

The FDA has approved ANDA216988 for Clonazepam submitted by Rubicon Research.

RegulatoryJuly 19, 2026

Granules' ANDA217027 for Amphetamine Products Receives FDA Approval

The FDA has approved ANDA217027 submitted by Granules for a combination of amphetamine products.

ClinicalJuly 19, 2026

Lavender Aromatherapy Trial for Cognitive Function in Older Adults with MCI

A clinical trial is underway to evaluate the effects of lavender aromatherapy on cognitive function in older adults with Mild Cognitive Impairment.

ClinicalJuly 19, 2026

Study on Deep Brain Stimulation's Impact on Eye Function in Parkinson's Disease

The study investigates the effects of deep brain stimulation on vergence impairment and strabismus in Parkinson's patients.

RegulatoryJuly 19, 2026

FDA Acceptance of Divalproex Sodium Supplement by Apotex

The FDA has accepted the supplemental application for Divalproex Sodium submitted by Apotex.

ClinicalJuly 19, 2026

Study on Genetic Basis of Developmental Language Disorder Launched

A new study aims to investigate the genetic basis of Developmental Language Disorder (DLD) using advanced genomic techniques.

RegulatoryJuly 19, 2026

FDA Accepts Supplement for Apomorphine Hydrochloride NDA214056

The FDA has accepted a supplemental application for Apomorphine Hydrochloride under NDA214056.

RegulatoryJuly 19, 2026

FDA Grants AP Status for OXCARBAZEPINE ANDA207717 Submission

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for OXCARBAZEPINE submitted by Rubicon Research.

ClinicalJuly 19, 2026

Study on TES-TI to Modulate Sleep Spindles in Schizophrenia Spectrum Disorders

A clinical trial is investigating the effects of transcranial electrical stimulation with temporal interference (TES-TI) on sleep spindles in individuals with schizophrenia spectrum disorders.

ClinicalJuly 18, 2026

Eccentric Training vs Standard Strength Training in Spinal Cord Injury Rehabilitation

A clinical trial is assessing the effects of eccentric arm-crank training versus standard strength training in spinal cord injury rehabilitation.

ClinicalJuly 18, 2026

Phase 2 Study of Ketamine-Induced phBOLD in Healthy Volunteers

A study is underway to evaluate the effects of ketamine on brain activity using pharmacoBOLD imaging in healthy volunteers.

RegulatoryJuly 18, 2026

FDA Approves Supplement for Tegretol (Carbamazepine) by Novartis

The FDA has approved a supplemental application for Tegretol, an antiepileptic drug containing carbamazepine.

StrategyJuly 18, 2026

FDA Grants Approval for Brivaracetam ANDA219766 by Shandong

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 219766 for Brivaracetam submitted by Shandong.

StrategyJuly 18, 2026

FDA grants AP status for Lamotrigine ANDA219677 by Taro

The FDA has granted Abbreviated Approval (AP) status for Taro's Lamotrigine ANDA219677.

RegulatoryJuly 18, 2026

FDA Grants AP Status for Alprazolam ANDA213204 by Unichem

The FDA has granted approval status (AP) for the ANDA213204 application for Alprazolam submitted by Unichem.

RegulatoryJuly 18, 2026

Hikma's Lithium Carbonate ANDA Receives Approval Status from FDA

Hikma's application for Lithium Carbonate has received an approval status (AP) from the FDA.

RegulatoryJuly 18, 2026

FDA Accepts Supplement for Oxcarbazepine by Kanchan Healthcare

The FDA has accepted a supplemental application for oxcarbazepine submitted by Kanchan Healthcare.

RegulatoryJuly 18, 2026

FDA Accepts Supplemental NDA for CREXONT by IMPAX

The FDA has accepted a supplemental NDA for CREXONT, a combination of carbidope and levodopa.

StrategyJuly 18, 2026

FDA Grants Approval for Lorazepam ANDA200542 by Rising

The FDA has granted approval for the ANDA200542 application for Lorazepam submitted by Rising.

StrategyJuly 17, 2026

FDA Grants Approval for Lamotrigine ANDA077420 by Rising

The FDA has granted approval for ANDA077420, a generic version of Lamotrigine, submitted by Rising.

RegulatoryJuly 17, 2026

FDA Submission Update for OXCARBAZEPINE by Rubicon Research

Rubicon Research has submitted a supplemental application for OXCARBAZEPINE (ANDA077747) with standard review priority.

RegulatoryJuly 17, 2026

FDA Accepts Supplement for MAVENCLAD by EMD Serono

The FDA has accepted a supplemental application for MAVENCLAD (cladribine) from EMD Serono.

ClinicalJuly 17, 2026

NIMH Initiates PET Imaging Study with New Tracer 11C-ARMI for Brain Research

The National Institute of Mental Health is testing a new radioactive tracer, 11C-ARMI, in healthy individuals to evaluate its effectiveness in imaging brain function.

ClinicalJuly 17, 2026

Daridorexant Trial Targets Insomnia and Alcohol Use Disorder

A clinical trial is underway to evaluate daridorexant's efficacy in reducing alcohol consumption and improving sleep in patients with insomnia and alcohol use disorder.

ClinicalJuly 17, 2026

Eptinezumab Trial for Pediatric Migraine Participants Initiated by Lundbeck

A clinical trial is underway to evaluate the efficacy of eptinezumab in reducing episodic migraine days in pediatric patients.

StrategyJuly 16, 2026

FDA Submission for Ubrogepant by Zydus Pharmaceuticals

Zydus Pharmaceuticals has submitted an ANDA for Ubrogepant, indicating a potential generic entry into the migraine treatment market.

RegulatoryJuly 16, 2026

FDA Grants Priority Review for LEQEMBI Supplement Application

The FDA has granted priority review status for the supplemental application of LEQEMBI (lecanemab-IRMB) submitted by Eisai Inc.

RegulatoryJuly 16, 2026

MHRA Strengthens Warnings for Botulinum Toxin Type A Products Due to Botulism Cases

The MHRA has issued updated safety warnings for botulinum toxin type A products due to rare cases of botulism.

RegulatoryJuly 16, 2026

Updated Warnings on Botulinum Toxin Type A Products Due to Iatrogenic Botulism Risk

Iatrogenic botulism cases have been reported following the use of botulinum toxin type A products, indicating a risk of toxin effects extending beyond treatment areas.

RegulatoryJuly 16, 2026

FDA Grants AP Status for Amantadine Hydrochloride ANDA210215

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Amantadine Hydrochloride submitted by POM Pharma.

ClinicalJuly 16, 2026

Febuxostat Evaluated for Intracranial Hemorrhage Treatment in Clinical Study

A clinical study is underway to evaluate the efficacy of Febuxostat in patients with conservatively managed intracranial hemorrhage.

RegulatoryJuly 15, 2026

FDA Accepts Supplemental NDA for Pyridostigmine Bromide by Amneal

The FDA has accepted a supplemental NDA for Pyridostigmine Bromide submitted by Amneal.

StrategyJuly 15, 2026

UMEDICA LABS Receives FDA Approval for Zolpidem Tartrate ANDA220717

UMEDICA LABS has received an Abbreviated New Drug Application (ANDA) approval for Zolpidem Tartrate.

RegulatoryJuly 15, 2026

FDA Accepts Supplement for XELSTRYM by Noven Pharmaceuticals

The FDA has accepted a supplemental application for XELSTRYM, an ADHD treatment containing dextroamphetamine.

RegulatoryJuly 15, 2026

FDA Accepts Supplement for Oxcarbazepine by Hetero Labs

The FDA has accepted a supplemental application for oxcarbazepine submitted by Hetero Labs.

CompetitiveJuly 15, 2026

Phase 3 Trial of Nizubaglustat for Niemann-Pick Type C Disease Initiated

Azafaros B.V. has initiated Phase 3 trial to assess the safety and efficacy of oral nizubaglustat in Niemann-Pick Type C disease.

RegulatoryJuly 15, 2026

FDA Accepts Supplement for Oxcarbazepine by Chartwell RX

The FDA has accepted a supplemental application for oxcarbazepine submitted by Chartwell RX.

StrategyJuly 14, 2026

FDA Approves Lamotrigine ANDA078625 by Rubicon Research

The FDA has approved ANDA078625 for Lamotrigine submitted by Rubicon Research.

RegulatoryJuly 14, 2026

FDA Grants Approval for Levetiracetam in Sodium Chloride by Mylan Labs

The FDA has granted approval for Mylan Labs' ANDA218364, a formulation of levetiracetam in sodium chloride.

ClinicalJuly 14, 2026

Novartis Evaluates Remibrutinib for Secondary Progressive Multiple Sclerosis

Novartis is conducting a study to assess the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis.

ClinicalJuly 14, 2026

Long-term Atogepant Study Shows Real-World Effectiveness for Migraine Prevention

A prospective multicentre observational study is evaluating atogepant's long-term effectiveness and safety for migraine prevention in real-world settings.

ClinicalJuly 14, 2026

Intranasal Insulin Shows Potential for Treating PTSD Symptoms

A clinical trial is underway to assess the efficacy of intranasal insulin in reducing symptoms of PTSD.

ClinicalJuly 14, 2026

Cleminorexton Study for Narcolepsy Type 1 and Type 2 Initiated by Centessa Pharmaceuticals

A clinical trial is underway to evaluate the safety and tolerability of cleminorexton in patients with Narcolepsy Type 1 and Type 2.

RegulatoryJuly 14, 2026

FDA Grants Priority Review for OCREVUS Supplemental Application

The FDA has granted priority review for the supplemental application of OCREVUS (ocrelizumab) submitted by Genentech.

RegulatoryJuly 14, 2026

FDA Approves Supplemental Application for NURTEC ODT by Pfizer

The FDA has approved a supplemental application for NURTEC ODT, an oral medication containing rimegepant sulfate.

RegulatoryJuly 14, 2026

FDA Approves First At-home Starting Dose for Leqembi in Alzheimer's Treatment

The FDA has approved a new starting dosage regimen for Leqembi, allowing for at-home administration.

ClinicalJuly 14, 2026

Bristol-Myers Squibb initiates Phase 3 trial for KarXT + KarX-EC in Alzheimer's agitation

A Phase 3 study has been launched to assess the safety and efficacy of KarXT + KarX-EC for treating agitation in Alzheimer's patients.

ClinicalJuly 14, 2026

Phase III Trial of Lecigon® in Parkinson's Disease Targets Neuropsychiatric Symptoms

A Phase III trial is underway to evaluate the efficacy of Lecigon® in reducing hyperdopaminergic symptoms in Parkinson's patients.

RegulatoryJuly 14, 2026

Aurobindo Pharma's ANDA216537 for Carbidope and Levodopa Receives AP Status

Aurobindo Pharma's ANDA216537 for a supplemental application of Carbidope and Levodopa has received an Abbreviated Approval (AP) status from the FDA.

ClinicalJuly 13, 2026

Elpida Therapeutics initiates MELPIDA trial for SPG50 using AAV9 gene therapy

Elpida Therapeutics is conducting a trial for MELPIDA, a gene therapy targeting SPG50, focusing on safety and tolerability.

ClinicalJuly 13, 2026

Phase 2b Study of Pirepemat Shows Promise for Reducing Falls in Parkinson's Patients

A Phase 2b clinical trial is underway to evaluate the efficacy and safety of pirepemat in reducing falls in Parkinson's disease patients.

RegulatoryJuly 13, 2026

Teva Pharmaceuticals Receives AP Status for Gabapentin Supplement

Teva Pharmaceuticals has received an Abbreviated Approval (AP) for a supplemental application for Gabapentin.

StrategyJuly 13, 2026

FDA Approval for Acetazolamide Sodium by Mylan

The FDA has approved ANDA200880 for Acetazolamide Sodium submitted by Mylan.

ClinicalJuly 13, 2026

Novartis initiates long-term follow-up study for OAV101 in Spinal Muscular Atrophy

Novartis is conducting a long-term follow-up study to evaluate the safety and efficacy of OAV101 over five years.

StrategyJuly 13, 2026

FDA Grants AP Status for Lamotrigine ANDA079204 by Taro

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Lamotrigine submitted by Taro.

ClinicalJuly 13, 2026

Trial on Treatment Options for Major Depressive Disorder with TRD Initiated

A multi-site trial is comparing aripiprazole augmentation, rTMS augmentation, and switching to venlafaxine XR or Duloxetine for TRD patients.

ClinicalJuly 13, 2026

NeuroDerm's ND0612 Study Evaluates Safety and Pharmacokinetics in Parkinson's Disease

A randomized, placebo-controlled study is underway to assess the safety and pharmacokinetics of ND0612 in Parkinson's disease patients.

RegulatoryJuly 12, 2026

FDA Grants AP Status for Valproic Acid ANDA091037 by Sun Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Valproic Acid submitted by Sun Pharma.

CompetitiveJuly 12, 2026

FDA Grants AP Status for Lorazepam ANDA200217 by Rising

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Lorazepam submitted by Rising.

CompetitiveJuly 12, 2026

FDA Approves ANDA for Bupropion Hydrochloride by Yichang Humanwell

The FDA has granted approval for ANDA220529 for Bupropion Hydrochloride submitted by Yichang Humanwell.

ClinicalJuly 12, 2026

Clinical Trial on Cannabidiol for Alcohol Withdrawal Symptoms Initiated

A randomized placebo-controlled trial is underway to assess the efficacy of cannabidiol (CBD) in treating alcohol withdrawal symptoms and cravings in individuals with moderate-to-severe alcohol use disorder.

RegulatoryJuly 12, 2026

Biogen initiates observational study on omaveloxolone's effects during pregnancy and breastfeeding

Biogen is conducting an observational study to assess the safety of BIIB141 (omaveloxolone) in pregnant and breastfeeding women with Friedrich's Ataxia.

StrategyJuly 12, 2026

Hetero Labs submits ANDA220421 for Vemagal with standard review priority

Hetero Labs Limited has submitted ANDA220421 for Vemagal, currently under standard review.

RegulatoryJuly 12, 2026

Teva's Gabapentin ANDA205807 Receives Approval Status from FDA

Teva Pharmaceuticals USA has received an approval status (AP) for its Abbreviated New Drug Application (ANDA205807) for Gabapentin.

ClinicalJuly 12, 2026

Pilot Study of Brincidofovir for Treating Progressive Multifocal Leukoencephalopathy

A pilot study is underway to evaluate the efficacy of intravenous Brincidofovir in patients with Progressive Multifocal Leukoencephalopathy (PML).

RegulatoryJuly 12, 2026

FDA Accepts Supplement for INBRIJA (Levodopa) by Merz

The FDA has accepted a supplemental application for INBRIJA, an inhaled formulation of levodopa, submitted by Merz.

RegulatoryJuly 12, 2026

FDA Approval Status Update for Deutetrabenazine by Aurobindo Pharma

Aurobindo Pharma's application for deutetrabenazine has been submitted and is under standard review.

ClinicalJuly 12, 2026

Study on Pediatric Extradural Hematoma Outcomes Post-Head Injury

The study focuses on the surgical and clinical outcomes of acute extradural hematoma in children following traumatic head injuries.

ClinicalJuly 12, 2026

Larimar Therapeutics Evaluates Nomlabofusp in Pediatric Friedreich's Ataxia Trial

Larimar Therapeutics is conducting a clinical trial to assess the safety and tolerability of nomlabofusp in adolescents and children with Friedreich's ataxia.

RegulatoryJuly 11, 2026

FDA Grants AP Status for Gabapentin ANDA213603 by Zhejiang Yongtai

The FDA has granted approval status (AP) for the ANDA213603 application for Gabapentin submitted by Zhejiang Yongtai.

StrategyJuly 11, 2026

Granules' Lamotrigine ANDA078982 Receives Approval Status

Granules has received an Approval Pending (AP) status for their ANDA078982 application for Lamotrigine.

StrategyJuly 11, 2026

FDA Approves Pregabalin ANDA219593 by Unichem

The FDA has approved the Abbreviated New Drug Application (ANDA) for Pregabalin submitted by Unichem.

RegulatoryJuly 11, 2026

FDA Acceptance of Supplement for AUVELITY by AXSOME

The FDA has accepted a supplemental application for AUVELITY, which includes bupropion hydrochloride and dextromethorphan hydrobromide.

StrategyJuly 11, 2026

FDA Grants Approval for Methylphenidate Hydrochloride ANDA205756

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for Methylphenidate Hydrochloride submitted by RISING.

StrategyJuly 11, 2026

FDA Grants AP Status for Zydus' Carbamazepine ANDA205571

The FDA has granted approval status (AP) for Zydus Pharmaceuticals' ANDA205571 for Carbamazepine.

ClinicalJuly 11, 2026

Phase I Trial of Ammoxetine Hydrochloride in Hepatic Impairment Patients

A Phase I clinical trial is underway to evaluate the pharmacokinetics and safety of ammoxetine hydrochloride in patients with varying degrees of hepatic impairment.

ClinicalJuly 11, 2026

Trial on Remifentanil and Dexmedetomidine for Blood Pressure Control in ICH Patients

A multicenter trial will assess the efficacy and safety of remifentanil and dexmedetomidine for blood pressure management in ICH.

ClinicalJuly 10, 2026

Network-Guided TMS Trial for Alzheimer's Behavioral Symptoms Initiated

A double-blind randomized controlled trial is underway to assess the safety and efficacy of personalized network-guided transcranial magnetic stimulation (TMS) for behavioral and psychological symptoms in Alzheimer's disease.

CompetitiveJuly 10, 2026

Lilly presents new Alzheimer's diagnostic and therapeutic data at AAIC 2026

Lilly will present new data on P-tau217 blood tests and insights from Kisunla trials at AAIC 2026.

ClinicalJuly 10, 2026

Study on Traumatic Brain Injury Pathogenesis and Outcomes by NINDS

A study is being conducted to evaluate MRI results and the natural evolution of traumatic brain injury over three months.

RegulatoryJuly 9, 2026

FDA Accepts Supplemental Application for MAYZENT (Siponimod) by Novartis

The FDA has accepted a supplemental application for MAYZENT (siponimod) submitted by Novartis.

ClinicalJuly 9, 2026

Study on Biomarkers in Fragile Sarcolemmal Muscular Dystrophy Launched

A clinical trial is underway to investigate biomarkers in individuals with fragile sarcolemmal muscular dystrophy, focusing on muscle enzyme changes.

ClinicalJuly 9, 2026

Trial on Ultrasound-Guided Cervical Plexus Block for VNS Surgery Analgesia

A clinical trial is evaluating the efficacy of ultrasound-guided intermediate cervical plexus block for pain management in vagus nerve stimulation surgery.

StrategyJuly 9, 2026

FDA Grants Approval for Brivaracetam ANDA219952 by Sciegen Pharmaceuticals

The FDA has granted approval for the Abbreviated New Drug Application (ANDA219952) for Brivaracetam submitted by Sciegen Pharmaceuticals.

RegulatoryJuly 9, 2026

Hikma's Acetazolamide Sodium ANDA040089 Receives AP Status from FDA

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'Approved' for Hikma's Acetazolamide Sodium.

RegulatoryJuly 9, 2026

FDA Accepts Supplemental NDA for ONAPGO (Apomorphine Hydrochloride)

The FDA has accepted a supplemental NDA for ONAPGO, indicating progress in regulatory review.

RegulatoryJuly 9, 2026

FDA Accepts Supplement for LEQSELVI (Deuruxolitinib Phosphate) by Sun Pharma

The FDA has accepted a supplemental application for LEQSELVI, an investigational treatment containing Deuruxolitinib Phosphate.

RegulatoryJuly 8, 2026

FDA Approves Supplemental Application for TASCENSO ODT

The FDA has approved a supplemental application for TASCENSO ODT, containing Fingolimod Lauryl Sulfate.

RegulatoryJuly 8, 2026

FDA Submission Update for CARBIDOPA; LEVODOPA by Zydus Pharms

Zydus Pharms USA Inc. has submitted an original application for CARBIDOPA; LEVODOPA under ANDA210911.

ClinicalJuly 8, 2026

Hoffmann-La Roche initiates trial for trontinemab in early symptomatic Alzheimer's disease

A clinical trial is underway to evaluate the efficacy and safety of trontinemab in early symptomatic Alzheimer's disease.

ClinicalJuly 8, 2026

Novel Remote Rehab Technique for Parkinson's Disease in Veterans

A new remote dynamic cycling rehabilitation technique is being tested for its efficacy in Parkinson's disease patients.

RegulatoryJuly 8, 2026

FDA Grants AP Status for Carbamazepine ANDA215591 by Zhejiang Jiuzhou

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Carbamazepine submitted by Zhejiang Jiuzhou.

RegulatoryJuly 8, 2026

FDA Accepts Supplemental Application for Copaxone (Glatiramer Acetate)

The FDA has accepted a supplemental application for Copaxone, a treatment for multiple sclerosis.

StrategyJuly 8, 2026

UMEDICA LABS Receives FDA Approval for OXCARBAZEPINE ANDA218341

UMEDICA LABS has received FDA approval for their Abbreviated New Drug Application (ANDA) for OXCARBAZEPINE.

RegulatoryJuly 8, 2026

FDA Accepts Aurobindo's Application for Cenobamate

The FDA has accepted Aurobindo Pharma's application for Cenobamate under ANDA219473.

RegulatoryJuly 8, 2026

FDA Accepts ANDA for Viloxazine Hydrochloride by Appco Pharma

The FDA has accepted the ANDA for Viloxazine Hydrochloride submitted by Appco Pharma.

RegulatoryJuly 8, 2026

FDA Grants AP Status for Dextroamphetamine and Amphetamine Combination Products

The FDA has granted approval status (AP) for ANDA211547, a combination of dextroamphetamine and amphetamine products.

RegulatoryJuly 7, 2026

FDA Grants AP Status for Gabapentin ANDA214957 by Ascent Pharm

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for gabapentin submitted by Ascent Pharm.

StrategyJuly 7, 2026

FDA Grants Approval for Doxepin Hydrochloride ANDA213919 by Sun Pharma

The FDA has granted approval for ANDA213919, a generic version of Doxepin Hydrochloride submitted by Sun Pharma.

RegulatoryJuly 7, 2026

FDA Accepts Supplemental NDA for NUPLAZID by ACADIA PHARMS

The FDA has accepted a supplemental NDA for NUPLAZID (pimavanserin tartrate) from ACADIA Pharmaceuticals.

ClinicalJuly 7, 2026

Study on SuPerSense Proprioceptive Rehabilitation in Parkinson's Disease

A randomized controlled trial is evaluating the feasibility and efficacy of the SuPerSense device for proprioceptive rehabilitation in Parkinson's disease.

ClinicalJuly 7, 2026

Roche to present new Alzheimer’s data, including trontinemab and pTau217 blood test, at AAIC 2026

Roche will present new long-term data on trontinemab and the Elecsys pTau217 blood test at AAIC 2026, highlighting advancements in Alzheimer's diagnostics and treatment.

ClinicalJuly 7, 2026

Roche presents new Alzheimer’s data at AAIC 2026, highlighting trontinemab and blood tests

Roche will present new long-term data on trontinemab and the Elecsys pTau217 blood test at AAIC 2026.

ClinicalJuly 7, 2026

APT Comparison Study to Evaluate Atogepant vs. Topiramate and Propranolol for Migraine Prevention

The APT Comparison Study will evaluate the effectiveness and tolerability of atogepant against topiramate and propranolol in migraine prevention.

ClinicalJuly 7, 2026

Digital Biomarkers for Monitoring Limb Function in Inclusion Body Myositis

A study is validating digital biomarkers for monitoring upper limb function in Inclusion Body Myositis using wearable sensors.

ClinicalJuly 6, 2026

Psilocybin Therapy Shows Promise for Depression in Parkinson's Disease

A clinical trial is underway to evaluate the efficacy of psilocybin therapy in patients with Parkinson's Disease and depression.

ClinicalJuly 6, 2026

Northwestern University Trials Behavioral Treatments for Narcolepsy-Related Nightmares

A clinical trial is underway to evaluate the effectiveness of imagery rehearsal therapy and targeted dream control for treating nightmares in narcolepsy patients.

ClinicalJuly 6, 2026

Vertex Pharmaceuticals Evaluates Suzetrigine's PK with Efavirenz in Healthy Participants

A study is underway to assess the pharmacokinetics and safety of Suzetrigine when co-administered with efavirenz.

RegulatoryJuly 6, 2026

FDA Accepts Supplement for CAPLYTA (Lumateperone) by INTRA-CELLULAR

The FDA has accepted a supplemental application for CAPLYTA (lumateperone) from INTRA-CELLULAR.

ClinicalJuly 6, 2026

UCB Biopharma initiates SLC6A1-NDD natural history study to inform future clinical trials

UCB Biopharma has launched a prospective longitudinal study to evaluate the natural history of SLC6A1-NDD.

RegulatoryJuly 6, 2026

FDA Grants Abbreviated Approval for Gabapentin by Ascent Pharmaceuticals

The FDA has granted an abbreviated approval for Gabapentin under application ANDA214956 submitted by Ascent Pharmaceuticals.

RegulatoryJuly 6, 2026

FDA Grants AP Status for Topiramate Supplement by Invagen Pharmaceuticals

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for a supplement of Topiramate submitted by Invagen Pharmaceuticals.

StrategyJuly 6, 2026

Alembic's ANDA207974 for Fingolimod Hydrochloride Receives Approval

The FDA has approved Alembic's Abbreviated New Drug Application (ANDA) for Fingolimod Hydrochloride.

RegulatoryJuly 5, 2026

FDA Accepts Supplement Application for VYVANSE by Takeda

The FDA has accepted a supplemental application for VYVANSE, an ADHD treatment, submitted by Takeda.

ClinicalJuly 5, 2026

KITE-363 Phase 1 Study Initiated for Autoimmune Neurologic Diseases

Kite, Gilead Company, is conducting Phase 1 study to evaluate the safety and efficacy of KITE-363 in patients with relapsed/refractory autoimmune neurologic diseases.

ClinicalJuly 5, 2026

Study on Language Recovery in Aphasia Investigates Treatment Effects

A study led by Northwestern University aims to assess treatment effects on language deficits in aphasia patients, measuring both cognitive and brain function changes.

ClinicalJuly 5, 2026

Study on Social Feedback's Impact on Intracranial EEG in Epilepsy Patients

A clinical trial is assessing how social feedback influences neural recordings in epilepsy patients during surgery.

RegulatoryJuly 5, 2026

Impax Labs Receives AP for Methylphenidate Hydrochloride ANDA205105

Impax Labs has received an Abbreviated Approval (AP) for its ANDA205105 application for Methylphenidate Hydrochloride.

RegulatoryJuly 5, 2026

FDA Grants AP Status for Levetiracetam Supplement by Strides Pharma

The FDA has granted Abbreviated Approval (AP) status for a supplement application of levetiracetam submitted by Strides Pharma.

StrategyJuly 5, 2026

FDA Submission Update for Dalfampridine by Accord Healthcare

Accord Healthcare has submitted an Abbreviated New Drug Application (ANDA) for Dalfampridine, currently under standard review.

RegulatoryJuly 5, 2026

FDA Accepts Supplemental NDA for Zuranolone (ZURZUVAE) by Biogen

The FDA has accepted a supplemental NDA for Zuranolone (ZURZUVAE) submitted by Biogen.

ClinicalJuly 5, 2026

Teikoku Pharma initiates trial for DMTS in Alzheimer's-related agitation

Teikoku Pharma USA is evaluating the efficacy of Dexmedetomidine Transdermal Systems for treating agitation in Alzheimer's patients.

RegulatoryJuly 4, 2026

FDA Grants AP Status for Carbamazepine ANDA219072 by Yichang Humanwell

The FDA has granted approval status (AP) for the ANDA219072 application for Carbamazepine submitted by Yichang Humanwell.

RegulatoryJuly 4, 2026

FDA Approves Lamotrigine Supplement from Glenmark Pharmaceuticals

The FDA has approved a supplement for Lamotrigine submitted by Glenmark Pharmaceuticals.

RegulatoryJuly 4, 2026

FDA Grants AP Status for Valproic Acid ANDA090517 by Quagen

The FDA has granted Abbreviated Approval (AP) status for Quagen's ANDA090517 for Valproic Acid.

ClinicalJuly 4, 2026

Study on LSD's Effect on Serotonin 2A Receptor Occupancy Initiated

A study is underway to quantify the relationship between LSD dosage, plasma levels, and serotonin 2A receptor occupancy.

ClinicalJuly 4, 2026

Study on rTMS for Mood Shifts in Bipolar Disorder Underway

A new study is investigating the efficacy of rTMS in treating depression in bipolar disorder by targeting individualized brain regions.

RegulatoryJuly 4, 2026

FDA Accepts Supplement for DIACOMIT (Stiripentol) by BIOCODEX SA

The FDA has accepted a supplemental application for DIACOMIT (Stiripentol) submitted by BIOCODEX SA.

ClinicalJuly 4, 2026

Esketamine Improves Postoperative Emotions and Immune Function in Acoustic Neuroma Surgery

A randomized clinical trial found that sub-anesthetic doses of esketamine may enhance immune function and reduce negative emotions post-surgery in acoustic neuroma patients.

RegulatoryJuly 4, 2026

FDA Grants AP Status for Buspirone Hydrochloride ANDA075388 by Oxford Pharms

The FDA has granted an Abbreviated Approval (AP) status for the ANDA075388 application for Buspirone Hydrochloride submitted by Oxford Pharms.

ClinicalJuly 4, 2026

NIMH Study on MRI and MRS Techniques for Brain Chemistry Imaging

The National Institute of Mental Health is developing and optimizing MRI and MRS techniques to study brain chemistry.

ClinicalJuly 3, 2026

Study on Bottle PEP Device Effects in Parkinson's Disease Patients

A clinical trial is investigating the impact of a low-cost bottle-PEP device on expiratory muscle strength and balance in Parkinson's disease patients.

ClinicalJuly 3, 2026

Astellas initiates first-in-human trial of ASP2246 for post-stroke movement disorders

Astellas Pharma has launched a first-in-human study of ASP2246 targeting movement problems following stroke.

RegulatoryJuly 3, 2026

FDA Grants Supplement Approval for DATSCAN (Ioflupane I-123)

The FDA has granted supplemental approval for DATSCAN, an imaging agent containing Ioflupane I-123.

RegulatoryJuly 3, 2026

FDA Accepts Supplemental Application for WAINUA Autoinjector by AstraZeneca

The FDA has accepted a supplemental application for the WAINUA autoinjector containing EPLONTERSEN SODIUM.

RegulatoryJuly 3, 2026

FDA Investigates Neurologic Risks of General Anesthesia Linked to Genetic Variant

The FDA is investigating severe neurologic complications associated with general anesthesia in patients of Venezuelan ancestry.

ClinicalJuly 3, 2026

Study Evaluates Lidocaine and Methylprednisolone for Headaches Post-Subarachnoid Hemorrhage

A clinical study is assessing the efficacy of lidocaine and methylprednisolone injections for headache relief in SAH patients.

ClinicalJuly 3, 2026

Study on Automated Parameter Optimization for Adaptive DBS in Parkinson's Disease

A new clinical trial aims to optimize adaptive deep brain stimulation (aDBS) parameters for Parkinson's disease patients using an automated, data-driven approach.

ClinicalJuly 3, 2026

Study on Predicting Migraine Attack Pain Using Hemodynamic Monitoring

A study is underway to predict migraine attack pain using premonitory symptoms and real-time hemodynamic monitoring.

RegulatoryJuly 3, 2026

Breckenridge's Milnacipran Hydrochloride ANDA205071 Receives AP Status

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status to Breckenridge for Milnacipran Hydrochloride.

RegulatoryJuly 3, 2026

Amneal Pharmaceuticals submits ANDA for Milnacipran Hydrochloride

Amneal Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) for Milnacipran Hydrochloride.

CompetitiveJuly 3, 2026

FDA Approves Lamotrigine Supplement from Alembic Pharmaceuticals

The FDA has approved a supplemental application for Lamotrigine submitted by Alembic Pharmaceuticals.

CompetitiveJuly 3, 2026

BioSensics to Validate Digital Health Tech for PSP and DLB Monitoring

BioSensics is leading a study to validate wearable digital health technologies for monitoring motor function in PSP, MCI-LB, and DLB.

ClinicalJuly 2, 2026

Eisai's Fycompa Injection Safety Study for Epilepsy Underway

Eisai is conducting a study to evaluate the safety of Fycompa injection in patients with partial-onset seizures and primary generalized tonic-clonic seizures.

ClinicalJuly 2, 2026

Trial Evaluates CBT and Sound Therapy for Chronic Tinnitus Management

A clinical trial is underway to assess the effectiveness of Cognitive Behavioral Therapy and Sound Therapy for chronic tinnitus.

ClinicalJuly 1, 2026

Phase 2 Trial of Daridorexant for PTSD Under Adaptive Platform Design

A Phase 2 trial is underway to evaluate daridorexant's safety and efficacy in PTSD patients.

RegulatoryJuly 1, 2026

FDA Grants AP Status for Gabapentin ANDA077661 by Rubicon Research

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Gabapentin submitted by Rubicon Research.

RegulatoryJuly 1, 2026

FDA Accepts Supplement for Xeomin (incobotulinumtoxinA) by Merz Pharmaceuticals

The FDA has accepted a supplemental application for Xeomin, a botulinum toxin product from Merz Pharmaceuticals.

ClinicalJuly 1, 2026

Deep Brain Stimulation Study for Movement Disorders Including Parkinson's Disease

A clinical trial is underway to evaluate the efficacy of deep brain stimulation (DBS) in adults with movement disorders such as Parkinson's disease, dystonia, and essential tremor.

RegulatoryJuly 1, 2026

FDA Grants AP Status for Valproic Acid ANDA073229 by Catalent

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Valproic Acid submitted by Catalent.

RegulatoryJuly 1, 2026

FDA Grants AP Status for Carbidope and Levodopa Supplement by Rubicon Research

The FDA has granted an Abbreviated New Drug Application (ANDA) AP status for a supplement of Carbidope and Levodopa submitted by Rubicon Research.

ClinicalJuly 1, 2026

Novartis initiates Phase I/II study of YTB323 in non-active Progressive Multiple Sclerosis

Novartis is conducting an open-label Phase I/II study to evaluate YTB323 in patients with non-active Progressive Multiple Sclerosis.

RegulatoryJune 30, 2026

FDA Accepts Supplemental Application for Emgality (Galcanezumab)

The FDA has accepted a supplemental application for Emgality, CGRP inhibitor developed by Eli Lilly.

ClinicalJune 30, 2026

Study on Vagus Nerve Stimulation in Parkinson's Disease Underway

A clinical trial is investigating the effects of transcutaneous vagus nerve stimulation on gut-brain communication in Parkinson's disease patients.

RegulatoryJune 30, 2026

FDA Accepts Supplemental Application for TRYNGOLZA Autoinjector

The FDA has accepted a supplemental application for the TRYNGOLZA autoinjector, indicating progress in its regulatory pathway.

RegulatoryJune 30, 2026

FDA Accepts Supplement for SPRAVATO (Esketamine) by Janssen

The FDA has accepted a supplemental application for SPRAVATO, an esketamine-based treatment.

ClinicalJune 30, 2026

Phase II Trial of HRS-7450 Injection for Acute Ischemic Stroke Initiated by Fujian Shengdi

Fujian Shengdi Pharmaceutical has initiated Phase II clinical trial for HRS-7450 Injection targeting Acute Ischemic Stroke.

RegulatoryJune 30, 2026

FDA Approves Supplemental Application for AJOVY (Fremanezumab)

The FDA has approved a supplemental application for AJOVY, a migraine treatment by Teva Pharmaceuticals.

RegulatoryJune 30, 2026

FDA Approves Supplemental Application for Epidiolex by Jazz Pharmaceuticals

The FDA has approved a supplemental application for Epidiolex, which contains cannabidiol as its active ingredient.

RegulatoryJune 30, 2026

FDA Accepts Supplement for VYEPTI (EPTINEZUMAB-JJMR) by Lundbeck

The FDA has accepted a supplemental application for VYEPTI, an anti-CGRP therapy for migraine.

ClinicalJune 30, 2026

Study on TBI Assessment Using TMS and Delphi-MD Device Initiated

A clinical trial assessing traumatic brain injury using transcranial magnetic stimulation has been initiated.

ClinicalJune 30, 2026

Study on Nerve Function in PIEZO2 Deficiency Syndrome Launched

A clinical trial has been initiated to assess nerve function in individuals with PIEZO2 Deficiency Syndrome compared to healthy volunteers.

RegulatoryJune 29, 2026

FDA Approves Supplement for Butalbital, Aspirin, Caffeine, and Codeine Phosphate

The FDA has approved a supplemental application for a combination product containing butalbital, aspirin, caffeine, and codeine phosphate.

ClinicalJune 29, 2026

Natural History Study of CADASIL Launched by NHLBI to Monitor Disease Progression

The NHLBI has initiated a long-term study to monitor the progression of CADASIL in affected individuals and healthy volunteers.

ClinicalJune 29, 2026

Bristol-Myers Squibb Evaluates KarXT for Bipolar-I Disorder Manic Episodes

A clinical trial is underway to assess the efficacy and safety of KarXT in treating manic episodes of Bipolar-I Disorder.

CompetitiveJune 28, 2026

NIH Investigates Exoskeletons for Children with Mobility Impairments

The NIH is conducting a study on a new exoskeleton device designed to assist children and young adults with mobility issues due to conditions like cerebral palsy and muscular dystrophy.

ClinicalJune 28, 2026

Study Compares Surgical Approaches for Carpal Tunnel Syndrome Relief

A clinical trial is underway to compare standard carpal tunnel release surgery with an extended approach that includes releasing the Lacertus fibrosus.

CompetitiveJune 28, 2026

Trial on Computerized Tool for Faster Brain Scan Diagnosis Initiated

A trial is underway to evaluate the effectiveness of a computerized tool (MIDI) in diagnosing brain scan issues more quickly.

ClinicalJune 28, 2026

Nevro Corp. Launches Global Study on SCS Therapy for Painful Diabetic Neuropathy

Nevro Corp. is conducting a global post-market study to evaluate its Spinal Cord Stimulation therapy for patients with chronic leg pain due to painful diabetic neuropathy.

ClinicalJune 28, 2026

Study on Inflammatory Biomarkers for Diagnosing Multiple Sclerosis

An observational study aims to identify inflammatory biomarkers that could aid in the diagnosis of multiple sclerosis (MS) and differentiate it from other CNS autoimmune diseases.

ClinicalJune 28, 2026

Study on rTMS Therapy for Neuropathic Pain in Spinal Cord Injury Patients

The study investigates the efficacy of high-frequency rTMS therapy on neuropathic pain and related outcomes in spinal cord injury patients.

ClinicalJune 28, 2026

Gut Proteobacteria Influence Cocaine Addiction via Glycine Metabolism in Mice

Cocaine exposure alters gut microbiome composition, increasing Proteobacteria and depleting glycine, which affects neuroplasticity and cocaine self-administration in mice.

RegulatoryJune 28, 2026

Novitium Pharma's Butalbital Combination Receives FDA Submission Approval

The FDA has approved a supplemental application for a combination product containing Butalbital, Aspirin, Caffeine, and Codeine Phosphate by Novitium Pharma.

ClinicalJune 28, 2026

University of Bern Trials Remote Cognitive Training for Alzheimer's Disease

A study is underway to assess the feasibility and usability of a tablet-based cognitive training program for Alzheimer's disease.

StrategyJune 27, 2026

Curaleaf Laboratories recalls Curaleaf Oil due to low THC content

Curaleaf Laboratories is recalling three batches of Curaleaf Oil due to low THC content.

ClinicalJune 27, 2026

Novartis initiates Phase I/II trial of YTB323 for treatment-resistant generalized myasthenia gravis

Novartis is conducting Phase I/II trial to evaluate the safety and efficacy of YTB323, CAR-T cell therapy, in patients with treatment-resistant generalized myasthenia gravis.

CompetitiveJune 27, 2026

Eli Lilly's Mazdutide Shows Promise in Alcohol Use Disorder Study

Eli Lilly is conducting a proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder.

ClinicalJune 27, 2026

Trial Compares Rivaroxaban and Ticagrelor Against Clopidogrel for Stroke Prevention

The trial aims to assess if rivaroxaban or ticagrelor, alone or in combination, is more effective than clopidogrel in reducing ischemic stroke and related outcomes.

RegulatoryJune 27, 2026

FDA Grants Priority Review for TRYNGOLZA Autoinjector Submission

The FDA has granted priority review for the supplemental application of TRYNGOLZA (olezarsen sodium) autoinjector by Ionis Pharmaceuticals.

RegulatoryJune 27, 2026

Aurobindo Pharma submits supplemental ANDA for Pregabalin

Aurobindo Pharma has submitted a supplemental Abbreviated New Drug Application (ANDA) for Pregabalin.

RegulatoryJune 27, 2026

FDA Approves ANDA for Bupropion Hydrochloride by Macleods

The FDA has approved ANDA218567 for Bupropion Hydrochloride submitted by Macleods Pharmaceuticals.

StrategyJune 27, 2026

FDA Grants Approval for Gabapentin ANDA203611 by Actavis Elizabeth

The FDA has granted approval for ANDA203611, a generic version of Gabapentin submitted by Actavis Elizabeth.

ClinicalJune 27, 2026

Study on NeuAngio-CT Impact on Acute Ischemic Stroke Intervention

This study evaluates the effectiveness of NeuAngio-CT equipped emergency stroke unit in reducing reperfusion time for acute ischemic stroke patients.

ClinicalJune 27, 2026

Feasibility Study for Platform Trial in Intracerebral Haemorrhage Patients

The University of Edinburgh is conducting a feasibility study to evaluate a platform trial design for adults with stroke due to intracerebral haemorrhage.

RegulatoryJune 27, 2026

FDA Approves Supplemental Application for Copaxone (Glatiramer Acetate)

The FDA has approved a supplemental application for Copaxone, a treatment for multiple sclerosis.

RegulatoryJune 26, 2026

FDA Approval Update for FIORICET with Codeine Supplement

The FDA has accepted a supplemental application for FIORICET with Codeine from Actavis Labs.

StrategyJune 26, 2026

Innovative model for treatment sequencing in relapsing-remitting multiple sclerosis

A new computer-assisted model has been developed to optimize treatment sequencing for relapsing-remitting multiple sclerosis based on expert opinions.

RegulatoryJune 26, 2026

FDA Accepts Supplemental BLA for OCREVUS ZUNOVO by Genentech

The FDA has accepted the supplemental BLA for OCREVUS ZUNOVO, which includes ocrelizumab and hyaluronidase.

ClinicalJune 26, 2026

Phase 3 Study of Radiprodil in GRIN-related Neurodevelopmental Disorder Initiated

The Phase 3 trial for radiprodil in GRIN-NDD has commenced, focusing on efficacy and safety in two cohorts.

ClinicalJune 26, 2026

Study on Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease Initiated

A prospective study is underway to evaluate the efficacy and safety of deep cervical lymphovenous anastomosis in severe Alzheimer's patients.

ClinicalJune 26, 2026

Trial on Cooling Treatments for Neonatal Hypoxic-Ischemic Encephalopathy Initiated

The Optimizing Cooling trial will compare four whole-body cooling treatments for infants with hypoxic-ischemic encephalopathy.

ClinicalJune 25, 2026

Long-Read Sequencing to Enhance Neurogenetic Diagnoses in Neurological Conditions

A clinical trial is underway to evaluate long-read sequencing and optical genome mapping for detecting nucleotide repeat expansions in patients with undiagnosed neurological conditions.

ClinicalJune 25, 2026

Study on NICardipine for Rapid BP Control in ICH Patients Initiated

A quality improvement study is assessing the effectiveness of nicardipine for achieving rapid systolic BP targets in ICH patients.

CompetitiveJune 25, 2026

Lilly acquires Centessa Pharmaceuticals to enhance sleep-wake disorder treatments

Eli Lilly has completed its acquisition of Centessa Pharmaceuticals, focusing on orexin receptor 2 agonists.

RegulatoryJune 25, 2026

FDA Accepts Supplement for FIORICET with Codeine

The FDA has accepted a supplemental application for FIORICET with Codeine from Actavis Labs.

ClinicalJune 24, 2026

Neurocrine's NBI-1065845 Shows Promise as Adjunctive Treatment for Major Depressive Disorder

A study is underway to assess the efficacy and safety of NBI-1065845 as an adjunctive treatment for Major Depressive Disorder.

RegulatoryJune 24, 2026

Sterling Pharmaceuticals recalls KidNaps Melatonin due to stability issues

Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are recalling all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution due to out of specification stability results.

ClinicalJune 24, 2026

AbbVie initiates trial for ubrogepant in menstrual migraine treatment

AbbVie is conducting a study to evaluate the safety and efficacy of ubrogepant for treating menstrual migraine in adult women.

ClinicalJune 24, 2026

Dianthus Therapeutics initiates Phase 2 trial for Claseprubart in multifocal motor neuropathy

Dianthus Therapeutics is conducting Phase 2 clinical trial to assess Claseprubart's safety and efficacy in adults with multifocal motor neuropathy.

RegulatoryJune 24, 2026

SyriMed recalls Baclofen oral solution due to crystallisation issues

Syri Limited is recalling Baclofen 10mg/5ml oral solution due to crystallisation observed over time.

StrategyJune 23, 2026

Hikma's ANDA for Solriamfetol Hydrochloride Receives Approval Status

Hikma's ANDA218016 for Solriamfetol Hydrochloride has received an Approval Pending status from the FDA.

StrategyJune 23, 2026

FDA Approves Solriamfetol Hydrochloride by Alkem Labs

The FDA has approved Solriamfetol Hydrochloride under application ANDA218722 submitted by Alkem Labs.

CompetitiveJune 23, 2026

Abbott's Study Compares Novel Spinal Cord Stimulation Techniques

A clinical trial is underway to compare a novel spinal cord stimulation lead implantation technique with a standard approach.

StrategyJune 23, 2026

Aurobindo Pharma's Divalproex Sodium ANDA202419 Receives AP Status

Aurobindo Pharma's Abbreviated New Drug Application for Divalproex Sodium has received an Approval Pending (AP) status.

ClinicalJune 23, 2026

Trial Compares VR and Dual-Task Training for Balance in Parkinson's Disease

A clinical trial is evaluating the efficacy of cognitive-based balance rehabilitation using Virtual Reality versus traditional Dual-Task Training in Parkinson's Disease patients.

ClinicalJune 23, 2026

Clinical Trial Evaluates Adaptive DBS for Parkinson's Disease Management

A clinical trial is underway to assess the efficacy and safety of an adaptive deep brain stimulation system for Parkinson's disease.

ClinicalJune 23, 2026

Study on Real-World Effectiveness of Rozanolixizumab in Myasthenia Gravis Patients

An observational study is underway to evaluate the real-world effectiveness of Rozanolixizumab in patients with generalized Myasthenia Gravis using a new patient-reported outcomes tool.

RegulatoryJune 22, 2026

FDA Accepts Supplemental Application for Epidiolex by Jazz Pharmaceuticals

The FDA has accepted a supplemental application for Epidiolex, indicating ongoing development and potential label expansion.

RegulatoryJune 22, 2026

FDA Approval Status for Cyclobenzaprine Hydrochloride Supplement

The FDA has issued an approval status for the supplement application ANDA072854 for Cyclobenzaprine Hydrochloride.

ClinicalJune 22, 2026

Study on PET Imaging in Gaucher Disease and Parkinsonism Launched

A new clinical trial is investigating dopamine usage in individuals with Gaucher disease and parkinsonism using PET imaging.

CompetitiveJune 22, 2026

Study on Baiobit® Sensor Reliability for Gait Assessment in Stroke Survivors

A study evaluating the reliability of the Baiobit® inertial sensor for gait assessment in stroke survivors is underway.

ClinicalJune 22, 2026

Study on VR Mirror Therapy for Stroke Patients Shows Promise

The study compares the effects of Virtual Reality Mirror Therapy with and without focused attention in stroke patients.

RegulatoryJune 22, 2026

Nipocalimab (Imaavy) Approved for Generalised Myasthenia Gravis Treatment

Nipocalimab (Imaavy) has been authorized by the MHRA for the treatment of adults and adolescents with generalised myasthenia gravis.

ClinicalJune 22, 2026

PREVENT ALL ALS Study Launches to Collect Data on Genetic Risk for ALS

The PREVENT ALL ALS study aims to gather extensive clinical data and samples from asymptomatic individuals at genetic risk for ALS over a 36-month period.

ClinicalJune 22, 2026

Study on Neuroimmune Diseases in Reproductive Age to Inform Pregnancy Management

A cohort study is investigating the impact of neuroimmune diseases on fertility and pregnancy outcomes over a five-year follow-up.

ClinicalJune 21, 2026

Progress on EBV Vaccine Development Critical for MS Prevention

Research indicates that Epstein-Barr virus (EBV) is a primary trigger for multiple sclerosis (MS), emphasizing the need for an effective vaccine.

ClinicalJune 21, 2026

Study on MRI Findings and Executive Functions in Preterm Infants

This study aims to correlate MRI findings at term age in preterm infants with their executive functions and neurodevelopmental outcomes.

ClinicalJune 21, 2026

Teva's TEV-56286 Trial for Multiple System Atrophy Underway

Teva is conducting a trial to evaluate the efficacy and safety of TEV-56286 in adults with Multiple System Atrophy.

ClinicalJune 21, 2026

New Observational Study on Treatment Adaptation in Status Epilepticus

An observational multicenter cohort study aims to improve treatment outcomes in adult patients with status epilepticus through enhanced monitoring and management strategies.

ClinicalJune 21, 2026

Study on Core Stability and Functional Capacity in Pediatric Demyelinating Diseases

A study is underway to assess various physical capabilities in children with CNS demyelinating diseases.

RegulatoryJune 21, 2026

FDA Accepts Supplement for Levetiracetam ANDA204754 by Aiping Pharm

The FDA has accepted a supplemental application for ANDA204754, a generic version of levetiracetam, from Aiping Pharm.

RegulatoryJune 21, 2026

FDA Accepts Supplemental Application for Emgality (Galcanezumab) by Eli Lilly

The FDA has accepted a supplemental application for Emgality, CGRP inhibitor developed by Eli Lilly.

RegulatoryJune 21, 2026

FDA Accepts Supplement for AJOVY (Fremanezumab) by Teva Pharmaceuticals

The FDA has accepted a supplemental application for AJOVY (fremanezumab) from Teva Pharmaceuticals.

ClinicalJune 21, 2026

Fremanezumab Trial for Acute Mountain Sickness Shows Potential for CGRP Blockade

A clinical trial is investigating the efficacy of fremanezumab in preventing symptoms of acute mountain sickness (AMS) in healthy adults.

RegulatoryJune 20, 2026

FDA Accepts Supplement for VYEPTI (EPTINEZUMAB-JJMR) by Lundbeck

The FDA has accepted a supplemental application for VYEPTI, an anti-CGRP therapy for migraine.

RegulatoryJune 20, 2026

FDA Grants AP Status for Acetazolamide Sodium ANDA202693

The FDA has granted approval status (AP) for the Abbreviated New Drug Application (ANDA) 202693 for Acetazolamide Sodium submitted by Avet Lifesciences.

RegulatoryJune 20, 2026

FDA Accepts ANDA for Dextromethorphan Hydrobromide and Quinidine Sulfate by Sun Pharma

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Dextromethorphan Hydrobromide and Quinidine Sulfate submitted by Sun Pharma.

ClinicalJune 20, 2026

Managed Access Program for Del-zota in DMD Patients Announced by Avidity Biosciences

Avidity Biosciences has launched Managed Access Program for delpacibart zotadirsen (AOC 1044) targeting DMD mutations suitable for exon 44 skipping.

ClinicalJune 20, 2026

Gene Transfer Study for Giant Axonal Neuropathy Initiated by NINDS

A clinical trial has been initiated to evaluate the safety and potential efficacy of scAAV9/JeT-GAN for treating Giant Axonal Neuropathy.

ClinicalJune 20, 2026

Study on Corticosteroids for Healing Ring-Enhancing Lesions in Multiple Sclerosis

A clinical trial is investigating the efficacy of high-dose corticosteroids on ring-enhancing lesions in MS patients.

RegulatoryJune 20, 2026

FDA Approves OTC Naloxone Nasal Spray Rextovy for Opioid Overdose

The FDA has approved Rextovy, a 4 mg naloxone nasal spray, for over-the-counter use in treating opioid overdose.

RegulatoryJune 19, 2026

Orbit Pharma recalls Cyclizine Lactate due to GMP deficiencies

Orbit Pharma Limited is recalling a batch of Cyclizine Lactate 50 mg/ml Solution for injection due to GMP deficiencies.

CompetitiveJune 19, 2026

Lupin's Divalproex Sodium ANDA209286 Receives Abbreviated Approval

Lupin has received an abbreviated approval for its ANDA209286 application for Divalproex Sodium.

RegulatoryJune 19, 2026

FDA Grants AP Status for Divalproex Sodium ANDA217358 by Mankind Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Divalproex Sodium submitted by Mankind Pharma.

StrategyJune 19, 2026

FDA Approves Hydroxyzine Hydrochloride ANDA220271 by Saptalis Pharmaceuticals

The FDA has approved ANDA220271 for Hydroxyzine Hydrochloride submitted by Saptalis Pharmaceuticals.

ClinicalJune 19, 2026

Study on Genotype-Phenotype Correlation of MORC2 Mutations in Charcot-Marie-Tooth Disease

A clinical trial is underway to investigate the correlation between MORC2 mutations and various phenotypes in patients.

ClinicalJune 19, 2026

Pilot Study on Deep Brain Stimulation for Opioid Use Disorder Initiated

A pilot study is underway to assess the safety and efficacy of deep brain stimulation targeting the nucleus accumbens in patients with treatment-refractory opioid use disorder.

ClinicalJune 19, 2026

Study on Emotional Wellness in Stroke Rehabilitation Initiated

A clinical trial is evaluating the impact of emotional wellness components in stroke rehabilitation therapies.

ClinicalJune 19, 2026

Study on Cardiovascular Abnormalities in Children with ADHD Launched

A new study has been initiated to assess the prevalence and types of cardiovascular abnormalities in children diagnosed with ADHD.

ClinicalJune 19, 2026

AbbVie Initiates Trial for ABBV-932 in Bipolar Disorder Depressive Episodes

AbbVie is conducting a trial to evaluate the safety and efficacy of ABBV-932 in adults with depressive episodes linked to bipolar I or II disorder.

ClinicalJune 19, 2026

Study on 'Yanjiu Needle' for Pharyngeal Dysphagia Shows Promise in Stroke Patients

'Yanjiu Needle' technique may improve swallowing function in stroke patients through specific acupoint stimulation.

ClinicalJune 19, 2026

Pilot trial to assess cognitive function changes in Rett Syndrome during Trofinetide treatment

A pilot trial will evaluate cognitive function changes in Rett Syndrome patients during Trofinetide treatment using eye-tracking measures.

ClinicalJune 18, 2026

Risdiplam Study to Assess Real-World Outcomes in Type I and II SMA

A multicenter study will evaluate the real-world clinical outcomes and safety of Risdiplam in SMA patients over 24 months.

RegulatoryJune 18, 2026

FDA Approves Supplemental Application for REXTOVY by Amphastar Pharmaceuticals

The FDA has approved a supplemental application for REXTOVY, containing naloxone hydrochloride.

StrategyJune 18, 2026

FDA Grants Approval for Lacosamide ANDA217596

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 217596 for lacosamide.

RegulatoryJune 18, 2026

TARO's ANDA219052 for PERAMPANEL Receives Approval Status

TARO's ANDA219052 for PERAMPANEL has received an approval status (AP) from the FDA.

CompetitiveJune 18, 2026

FDA Submission Update for Topiramate by Aiping Pharm Inc.

Aiping Pharm Inc. has submitted an application (ANDA078499) for Topiramate with a standard review priority.

RegulatoryJune 18, 2026

FDA Accepts Supplement for Clonazepam by Rubicon Research

The FDA has accepted a supplemental application for Clonazepam submitted by Rubicon Research.

StrategyJune 18, 2026

Cipla's ANDA214209 for Sumatriptan Receives Abbreviated Approval from FDA

Cipla has received Abbreviated Approval (AP) from the FDA for its ANDA214209 application for Sumatriptan.

StrategyJune 18, 2026

FDA Approval Update for Divalproex Sodium by Mylan

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for Divalproex Sodium submitted by Mylan.

StrategyJune 18, 2026

FDA Grants Abbreviated Approval for Divalproex Sodium by Unichem

The FDA has granted an abbreviated approval for Divalproex Sodium under application ANDA214643 submitted by Unichem.

RegulatoryJune 18, 2026

FDA Accepts Supplement Application for ENSPRYNG (Satralizumab)

The FDA has accepted the supplemental application for ENSPRYNG (satralizumab) submitted by Genentech.

ClinicalJune 17, 2026

Launch of Alzheimer's Disease Neuroimaging Initiative 4 to Validate Biomarkers

The Alzheimer's Disease Neuroimaging Initiative 4 (ADNI4) aims to validate biomarkers and improve clinical trial design for Alzheimer's disease.

ClinicalJune 17, 2026

Phase 3 Trial of Orelabrutinib in Secondary Progressive MS Underway

A phase 3 trial is evaluating the efficacy and safety of orelabrutinib, CNS-penetrable BTK inhibitor, in patients with non-active Secondary Progressive MS.

ClinicalJune 17, 2026

Analysis Reveals Key Trends in ALS Immunotherapeutics Research and Collaboration Gaps

The bibliometric analysis highlights a significant increase in ALS immunotherapeutics research, with a shift towards advanced immunomodulatory strategies and regulatory T cell modulation.

ClinicalJune 17, 2026

ACADIA Pharmaceuticals initiates ACP-204 trials for Alzheimer's Disease Psychosis

ACADIA Pharmaceuticals is launching a master protocol for three independent studies evaluating ACP-204 in Alzheimer's Disease Psychosis.

ClinicalJune 17, 2026

Roche's ENSPRYNG shows 68% relapse reduction in Phase III MOGAD study

The Phase III METEOROID study demonstrated that ENSPRYNG (satralizumab) reduced the risk of relapses by 68% in MOGAD patients.

RegulatoryJune 16, 2026

Roche's Elecsys® pTau217 Blood Test Receives CE Mark for Alzheimer's Detection

Roche has received CE Mark approval for Elecsys® pTau217, the first blood test designed to detect Alzheimer's disease pathology.

RegulatoryJune 16, 2026

Roche's Elecsys® pTau217 Blood Test Receives CE Mark for Alzheimer's Diagnosis

Roche has received CE Mark approval for Elecsys® pTau217, the first blood test for Alzheimer's disease pathology, enabling faster diagnosis.

ClinicalJune 10, 2026

Pridopidine Phase 3 Trial Initiated for ALS Efficacy and Safety Evaluation

A Phase 3 clinical trial is underway to evaluate the efficacy and safety of pridopidine in treating amyotrophic lateral sclerosis (ALS).

RegulatoryJune 10, 2026

FDA Accepts Supplement for SPRAVATO (Esketamine Hydrochloride)

The FDA has accepted a supplemental application for SPRAVATO, indicating ongoing development and potential label expansion.

StrategyJune 9, 2026

FDA Grants Approval for Pimozide ANDA219897 by Novitium Pharma

The FDA has granted approval for ANDA219897, a generic formulation of Pimozide submitted by Novitium Pharma.

RegulatoryJune 9, 2026

FDA Accepts Supplemental Application for Concerta by Janssen

The FDA has accepted a supplemental application for Concerta, a medication containing methylphenidate hydrochloride.

RegulatoryJune 7, 2026

Glenmark Pharmaceuticals submits supplemental application for Lamotrigine

Glenmark Pharmaceuticals has submitted a supplemental application for Lamotrigine under ANDA090169, currently under standard review.

RegulatoryJune 7, 2026

Alembic's Duloxetine Hydrochloride Supplement Receives AP Status from FDA

Alembic's application for Duloxetine Hydrochloride has received an Abbreviated Approval (AP) status from the FDA.

StrategyJune 6, 2026

Aurobindo Pharma's Lamotrigine ANDA Submission Receives AP Status

Aurobindo Pharma's ANDA078956 for Lamotrigine has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryJune 6, 2026

FDA Approves Supplement for Levetiracetam by Chartwell RX

The FDA has approved a supplemental application for levetiracetam submitted by Chartwell RX.

Companies

Assets

Recent signals(415)

Rimegepant Study in Adolescents with Frequent Migraine Begins Enrollment

KarXT Study for Bipolar-I Disorder Mania Shows Potential Efficacy

FDA Grants AP Status for Carbamazepine ANDA207798 by UMEDICA

Teva's Gabapentin ANDA075435 Receives AP Status from FDA

HI-tACS Trial Aims to Improve Executive Control in Gambling Disorder Patients

MSC-Exosome Therapy Shows Promise for Frontotemporal Dementia Treatment

FDA Grants AP Status for Acetazolamide Sodium ANDA200880

iVEAcare Neuromodulation System Study for Drug-Resistant Epilepsy Underway

Study on Transcranial Pulse Stimulation for Alzheimer's Disease Safety and Efficacy

ALKS 2680 Shows Promise in Reducing Sleepiness and Cataplexy in Narcolepsy Type 1

QIVIGY Study Initiated for Stiff Person Syndrome Efficacy and Safety

Phase I Trial of High-Density Theta Burst Stimulation (hdTBS) Initiated

FDA Approves Lamotrigine Supplement Application by Taro

FDA Grants Approval for Valproic Acid Supplement by Sun Pharma

FDA Grants Approval for Bupropion Hydrochloride by Yichang Humanwell

FDA Grants Approval for Gabapentin Supplement by Zhejiang Yongtai

Exploratory Study of UX-DA001 in Parkinson's Disease Shows Potential for Motor Function Improvement

Teva's Gabapentin ANDA205807 Receives AP Status from FDA

FDA Approves Supplement for Deutetrabenazine by Aurobindo Pharma

FDA Grants AP Status for Lamotrigine ANDA078982 by Granules

Eptinezumab shows promise for migraine prevention in new study

FDA Approves Pregabalin Application ANDA219593 by Unichem

FDA Submission Update for AXSOME's AUVELITY (NDA215430)

FDA Accepts Supplemental NDA for REXULTI (Brexpiprazole)

FDA Approves QLONILIK (Clonidine Hydrochloride) NDA221094

FDA Acceptance of Lacosamide Supplement by MSN Labs

Baxter Healthcare's Diazepam ANDA219882 Receives Approval Status

FDA Approves Supplement for HETLIOZ (Tasimelteon) by Vanda Pharmaceuticals

FDA Approves Supplement for Methylphenidate by Mylan Tech Viatris

FDA Approval Process Update for OXCARBAZEPINE by UMEDICA LABS

FDA Approval Process Update for Methylphenidate Hydrochloride by Rising

FDA Approval Status Update for Carbamazepine ANDA205571 by Zydus Pharmaceuticals

Aurobindo Pharma submits original application for Cenobamate

FDA Approval Process Update for Gabapentin ANDA214957

Study on IVIG for Neurological Symptoms in Long COVID Patients

Study Evaluates Anterior Carpal Ligament Biopsy for Early Detection of ATTR

FDA Grants Abbreviated Approval for Dextroamphetamine Combination Products

FDA Approves Doxepin Hydrochloride Application by Sun Pharma

Trial on TMS for Early Alzheimer's Disease Shows Potential Efficacy

FDA Grants Priority Review for NUPLAZID Supplement NDA210793

FDA grants priority review for NUPLAZID supplemental application

Virtual Reality for Cognitive Remediation in Elderly Patients with Depression

Study on Focused Ultrasound for Recovery After Severe Brain Injury Initiated

FDA Approves Lamotrigine ANDA206382 Submission by Sciegen Pharmaceuticals

Lupin's Diazepam ANDA220365 Receives Approval Status from FDA

Study on rTMS for PTSD in Veterans Aims to Understand Mechanisms of Action

FDA Grants Priority Review for Otsuka's Simtriyo (Centanafadine)

FDA Grants Approval for Biocon's Topiramate ANDA220943

FDA Approves Fingolimod Hydrochloride Application by Alembic

FDA Grants Approval for Gabapentin ANDA214956 by Ascent Pharm Inc.

FDA Accepts Supplemental NDA for CAPLYTA (Lumateperone Tosylate)

FDA Grants AP Status for Topiramate ANDA079162 by Invagen Pharmaceuticals

Web-based CBT for Insomnia in Dementia Caregivers: A New Study Launch

FDA Grants Priority Review for Otsuka's Simtriyo (Centanafadine)

Trial Initiated for CBD Effects on Alzheimer's Disease Biomarkers

FDA Accepts Supplemental Application for TYRUKO (Natalizumab-SZTN)

FDA Grants Approval for Zydus' Edaravone ANDA218349

FDA Accepts Supplemental NDA for NEURACEQ by Lantheus

FDA Grants AP Status for Aurobindo's Bupropion Hydrochloride

FDA Accepts Supplemental Application for ZYBAN by GlaxoSmithKline

FDA Accepts Supplement for Vyvanse (NDA 208510) from Takeda

FDA Accepts Supplemental Application for Vyvanse by Takeda

FDA Submission Update for Adderall XR 10 by Takeda

FDA Accepts Supplement for MYDAYIS by Takeda

Impax Labs receives FDA approval for Methylphenidate Hydrochloride supplement

FDA Grants AP Status for Levetiracetam Supplement by Strides Pharma

FDA Accepts Supplement for Dalfampridine by Accord Healthcare

Study on Physical Activity's Impact on Self-esteem in Alzheimer's Patients

Takeda's TAK-360 Trial for Narcolepsy Type 1 Underway

FDA Accepts Supplemental NDA for Biogen's Zuranolone (ZURZUVAE)

FDA Grants AP Status for Carbamazepine ANDA219072 by Yichang Humanwell

FDA Accepts Lamotrigine Supplement Application from Glenmark

FDA Approves Supplement for Valproic Acid by Quagen

FDA Accepts Supplemental Application for Diacomit (Stiripentol)

Phase II Study Links Chronic Hypoxia to Multiple System Atrophy Risk in Han Chinese

Study on Interdisciplinary Program to Enhance Quality of Life in Fibromyalgia Patients

Ravulizumab Study in Chinese Adults with Generalized Myasthenia Gravis Initiated by Alexion