The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Sertraline Hydrochloride submitted by Heritage Pharma Avet.

RegulatoryAugust 5, 2026

FDA Approves Supplement for Risperidone by Heritage Pharma

The FDA has approved a supplement for the ANDA076228 application for Risperidone submitted by Heritage Pharma.

ClinicalAugust 4, 2026

Semaglutide (Wegovy) Under Investigation for Trichotillomania Treatment

A clinical trial is underway to evaluate the safety and effectiveness of semaglutide for treating trichotillomania.

ClinicalAugust 4, 2026

Feasibility Study of UP-A-AST for Adolescents with Autism and Anxiety/Depression

A study is evaluating the feasibility and effects of the UP-A-AST Parent Group for adolescents with ASD and co-occurring anxiety/depression.

ClinicalAugust 3, 2026

Study Evaluates CO2 Biomarker for Predicting Therapy Response in Anxiety Disorders

A study is assessing the predictive power of CO2 challenge biomarker for response to exposure-based therapy in anxiety disorders.

ClinicalAugust 3, 2026

Study Compares Behavioral Therapy vs. Memantine for Body Focused Repetitive Behaviors

A clinical trial is underway to evaluate the efficacy of behavioral treatment versus memantine in patients with trichotillomania and skin picking disorder.

RegulatoryAugust 3, 2026

FDA Approval Process Update for Perphenazine by Zydus Pharmaceuticals

The FDA has an active application (ANDA205232) for Perphenazine submitted by Zydus Pharmaceuticals, currently under review.

RegulatoryAugust 2, 2026

FDA Accepts Application for Fluvoxamine Maleate by APPCO

The FDA has accepted the application ANDA220328 for Fluvoxamine Maleate submitted by APPCO.

RegulatoryAugust 2, 2026

FDA Approves Supplemental Application for Perseris Kit by Indivior

The FDA has approved a supplemental application for the Perseris Kit, which contains risperidone.

ClinicalAugust 2, 2026

Light Therapy Shows Promise for Depression in Pediatric HSCT Recipients

A clinical trial is evaluating the efficacy of blue light therapy for treating depression in children undergoing hematopoietic stem cell transplants.

ClinicalAugust 2, 2026

Study on Music's Impact on Emotion Recognition in Depressed Elderly Population

A study is assessing how positive music affects facial emotion recognition in elderly patients with depression.

ClinicalAugust 1, 2026

RCT to Evaluate Outpatient Treatment for Adolescents with Substance Use and Internalizing Disorders

A randomized clinical trial will compare a new psychosocial treatment for adolescents with co-occurring substance use and internalizing disorders against an active placebo.

RegulatoryJuly 31, 2026

FDA Grants TA for Viloxazine Hydrochloride Application ANDA220326

The FDA has granted Tentative Approval (TA) for Viloxazine Hydrochloride under application ANDA220326 submitted by Appco Pharma LLC.

ClinicalJuly 31, 2026

Mobile App-Delivered ACT Shows Efficacy in PTSD Treatment in China

A secondary analysis of a randomized controlled trial indicates that mobile app-delivered Acceptance and Commitment Therapy significantly improves PTSD symptoms through mediating components of psychological flexibility.

ClinicalJuly 31, 2026

PPMT shows feasibility and acceptability in PTSD treatment, insights for protocol refinement

A pilot trial of the Processing of Positive Memories Technique (PPMT) indicated strong feasibility and acceptability among clients and therapists for treating PTSD.

ClinicalJuly 30, 2026

Pilot Study on Psychotherapy for PTSD in HIV Patients

A pilot study is exploring a non-exposure based psychotherapy for PTSD in people living with HIV.

RegulatoryJuly 29, 2026

FDA Approves Supplemental Application for Ziprasidone Hydrochloride

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

StrategyJuly 28, 2026

FDA Approves Escitalopram Oxalate Application by Micro Labs

The FDA has approved the ANDA091655 application for Escitalopram Oxalate submitted by Micro Labs.

StrategyJuly 28, 2026

FDA grants AP status for Quetiapine Fumarate ANDA206252 by Accord Healthcare

The FDA has granted approval status (AP) for the ANDA206252 application for Quetiapine Fumarate submitted by Accord Healthcare.

ClinicalJuly 27, 2026

Study on CBT-I Efficacy in Adolescents with ADHD Initiated

A new study is evaluating the efficacy of Cognitive-Behavioral Therapy for Insomnia (CBT-I) in adolescents with ADHD, addressing comorbid insomnia.

ClinicalJuly 27, 2026

Study on Imagery Rescripting vs Exposure for OCD by King's College London

A study is underway to compare the effectiveness of imagery rescripting versus exposure therapy for OCD.

RegulatoryJuly 26, 2026

FDA grants AP status for Saptalis' Sonazine (Chlorpromazine Hydrochloride)

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Sonazine, a chlorpromazine hydrochloride product from Saptalis Pharmaceuticals.

StrategyJuly 26, 2026

FDA Grants AP Status for Lurasidone Hydrochloride ANDA208055

The FDA has granted approval status (AP) for the ANDA208055 application for Lurasidone Hydrochloride submitted by Torrent.

StrategyJuly 26, 2026

Edge+Ease PM+AM System Trial Evaluates Mood and Sleep Quality in Healthy Adults

A clinical trial is underway to assess the effects of the Edge+Ease PM+AM dietary supplement on mood, sleep quality, and digestive wellbeing in healthy adults.

ClinicalJuly 25, 2026

University of Minnesota Trials Cognitive Strategies in Early Psychosis with Modafinil and D-Serine

A clinical trial is investigating the effects of modafinil and d-serine on decision making in individuals with psychosis spectrum disorders.

StrategyJuly 25, 2026

FDA Grants Approval for Fluvoxamine Maleate ANDA220447 by Zydus Pharms

The FDA has granted approval for ANDA220447, a generic version of Fluvoxamine Maleate, submitted by Zydus Pharms.

RegulatoryJuly 24, 2026

FDA Approval Status Update for Doxepin Hydrochloride by Mylan

The FDA has granted an approval status (AP) for the supplemental application ANDA070791 for Doxepin Hydrochloride submitted by Mylan.

ClinicalJuly 23, 2026

University of Maryland Evaluates Suvorexant for Reducing Drug Demand

A clinical trial is underway to assess the efficacy of suvorexant in reducing drug demand and subjective liking.

ClinicalJuly 23, 2026

Post-ICU PTSD Intervention Shows Potential for Improving Quality of Life

A secondary analysis of the PICTURE trial indicates that a brief primary care intervention may improve health-related quality of life in ICU survivors with PTSD symptoms.

StrategyJuly 23, 2026

Heritage Pharma's Sertraline Hydrochloride ANDA077345 Receives AP Status

Heritage Pharma's application for Sertraline Hydrochloride has received an Abbreviated Approval (AP) status from the FDA.

ClinicalJuly 23, 2026

Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety Trial Initiated

A clinical trial is underway to evaluate the effectiveness of gaze-contingent music reward therapy (GCMRT) combined with cognitive behavioral therapy (CBT) for children with anxiety disorders.

StrategyJuly 22, 2026

FDA Grants Approval for Lurasidone Hydrochloride ANDA208047 by Dr. Reddy's

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

CompetitiveJuly 21, 2026

Phase II Trial of Teleo Virtual Therapy Platform for Youth Psychotherapy Engagement

A Phase II trial is underway to assess the engagement levels of children using the Teleo virtual therapy platform compared to standard video conferencing.

RegulatoryJuly 20, 2026

Aurobindo Pharma's Olanzapine ANDA203708 Receives AP Status from FDA

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

RegulatoryJuly 19, 2026

FDA Grants Supplement Approval for Lurasidone Hydrochloride by Amneal Pharmaceuticals

The FDA has granted approval for a supplemental application for Lurasidone Hydrochloride submitted by Amneal Pharmaceuticals.

StrategyJuly 19, 2026

FDA Grants Approval for Mirtazapine ANDA220104 by Micro Labs

The FDA has granted approval for the ANDA220104 application for Mirtazapine submitted by Micro Labs.

RegulatoryJuly 19, 2026

Aurobindo Pharma's Lurasidone Hydrochloride ANDA208045 Receives AP Status

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

StrategyJuly 19, 2026

FDA Grants Approval for Lurasidone Hydrochloride ANDA208028

The FDA has granted approval for ANDA208028, a generic version of Lurasidone Hydrochloride, submitted by InvaGen Pharmaceuticals.

ClinicalJuly 18, 2026

Study on Perimenopause-Related Mood Disorders Examines Hormonal Impact

An observational study will investigate the relationship between hormonal changes and mood disorders in perimenopausal women.

ClinicalJuly 18, 2026

Study on Non-invasive Vagus Nerve Stimulation for PTSD Underway

A study is being conducted to evaluate the effects of non-invasive vagus nerve stimulation on fear learning in PTSD patients.

ClinicalJuly 18, 2026

Study on MicroRNAs as Biomarkers for Suicidality in Adolescents

A clinical trial is underway to identify biomarkers for depression and suicidality in adolescents, focusing on neural-derived plasma exosomal microRNAs.

ClinicalJuly 17, 2026

Study on Exercise Impact on Mental Health in Psychiatric Inpatients Initiated by Johns Hopkins

A placebo-controlled study will assess the effects of exercise on neuropsychiatric symptoms in psychiatric inpatients.

RegulatoryJuly 16, 2026

FDA Acceptance of Supplemental Application for Lurasidone Hydrochloride by Zydus Pharms

The FDA has accepted the supplemental application ANDA208052 for Lurasidone Hydrochloride submitted by Zydus Pharms.

ClinicalJuly 15, 2026

Phase II Trial of Pramipexole vs Escitalopram for MDD in HIV Patients

A phase II trial is underway comparing pramipexole ER and escitalopram for treating MDD in HIV patients.

RegulatoryJuly 14, 2026

FDA Accepts Supplemental Application for Zyprexa Relprevv by Cheplapharm

The FDA has accepted a supplemental application for Zyprexa Relprevv, an antipsychotic medication.

StrategyJuly 14, 2026

FDA Grants Approval for Paliperidone ANDA205402 by I3 PHARMS

The FDA has granted approval for ANDA205402, a generic formulation of paliperidone, submitted by I3 PHARMS.

StrategyJuly 13, 2026

Heritage Pharma's Sertraline Hydrochloride ANDA Submission Receives AP Status

Heritage Pharma's ANDA for Sertraline Hydrochloride has been granted Abbreviated Approval (AP) status.

StrategyJuly 13, 2026

FDA Approval Update for Risperidone by Heritage Pharma

Heritage Pharma has received an Abbreviated New Drug Application (ANDA) approval for Risperidone.

RegulatoryJuly 11, 2026

FDA Grants AP Status for Zydus' Perphenazine Supplement

The FDA has granted an Abbreviated New Drug Application (ANDA) AP status for Zydus Pharmaceuticals' supplement for Perphenazine.

RegulatoryJuly 11, 2026

FDA Accepts ANDA for Fluvoxamine Maleate by APPCO

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Fluvoxamine Maleate submitted by APPCO.

RegulatoryJuly 11, 2026

FDA Accepts Supplement for REXULTI (Brexpiprazole) Submission

The FDA has accepted a supplemental application for REXULTI (brexpiprazole) from Otsuka.

RegulatoryJuly 11, 2026

FDA Approves Supplemental Application for PERSERIS Kit by INDIVIOR

The FDA has approved a supplemental application for the PERSERIS Kit, which contains risperidone.

RegulatoryJuly 9, 2026

FDA Accepts Supplement for Risperidone by Actavis Labs

The FDA has accepted a supplemental application for Risperidone submitted by Actavis Labs.

RegulatoryJuly 8, 2026

FDA Approves Supplemental Application for Strattera by Lilly

The FDA has approved a supplemental application for Strattera (atomoxetine hydrochloride) submitted by Lilly.

RegulatoryJuly 6, 2026

FDA Accepts Supplement for Ziprasidone Hydrochloride by Chartwell RX

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

StrategyJuly 5, 2026

FDA Approves ANDA for Escitalopram Oxalate by Micro Labs

The FDA has granted approval for ANDA091655, a generic version of Escitalopram Oxalate submitted by Micro Labs.

ClinicalJuly 4, 2026

Study on Oxytocin's Impact on Trust in Borderline Personality Disorder Patients

The study investigates the effects of intranasal oxytocin on trust behaviors in BPD patients compared to healthy adults.

RegulatoryJuly 3, 2026

FDA Accepts Supplement for Sonazine (Chlorpromazine Hydrochloride)

The FDA has accepted a supplemental application for Sonazine, a formulation of Chlorpromazine Hydrochloride, by Saptalis Pharmaceuticals.

RegulatoryJuly 1, 2026

FDA Grants AP Status for Haloperidol Decanoate ANDA214507

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Haloperidol Decanoate submitted by Meitheal.

ClinicalJuly 1, 2026

Study on Psychological Treatments for Youth with Disruptive Mood Dysregulation Disorder

A clinical trial is underway to evaluate the efficacy of Cognitive Behavioral Therapy and Interpretation Bias Training for children aged 8-17 with DMDD.

StrategyJuly 1, 2026

Hikma's Levomilnacipran Hydrochloride ANDA210732 Receives AP Status

The FDA has granted Abbreviated Approval (AP) status for Hikma's ANDA210732 for Levomilnacipran Hydrochloride.

ClinicalJune 30, 2026

Pilot Study of Mobile App for Binge Eating in Adolescents

A pilot study is underway to test a mobile app intervention aimed at adolescents with dysregulated eating behaviors.

ClinicalJune 30, 2026

Non-Inferiority Trial of TrIGR for PTSD Shows Promise Against Standard Therapy

A non-inferiority trial is underway to compare Trauma Informed Guilt Reduction Therapy (TrIGR) with cognitive processing therapy (CPT) for PTSD treatment in Veterans.

StrategyJune 30, 2026

FDA Grants Approval for Haloperidol ANDA214470 by Alembic

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 214470 for Haloperidol submitted by Alembic.

ClinicalJune 29, 2026

MI078 Capsules Show Promise in Treating Postpartum Depression

A multicenter, randomized, double-blind, placebo-controlled trial is underway to evaluate MI078 capsules for postpartum depression.

RegulatoryJune 27, 2026

FDA Approves ANDA220768 for Fluvoxamine Maleate by Micro Labs

The FDA has approved the Abbreviated New Drug Application (ANDA220768) for Fluvoxamine Maleate submitted by Micro Labs.

RegulatoryJune 23, 2026

FDA Accepts Supplement for Fluoxetine Hydrochloride by Sciegen Pharmaceuticals

The FDA has accepted a supplemental application for Fluoxetine Hydrochloride submitted by Sciegen Pharmaceuticals.

StrategyJune 23, 2026

FDA Grants Approval for Atomoxetine Hydrochloride ANDA218875

The FDA has granted approval for ANDA218875, a generic version of Atomoxetine Hydrochloride by Creekwood Pharmaceuticals.

RegulatoryJune 23, 2026

Cadila Pharmaceuticals Issues Class 4 Defect Notification for Mirtazapine 30mg Tablets

Cadila Pharmaceuticals Limited reported a defect in the EAN barcode on Mirtazapine 30mg tablets, affecting distribution.

ClinicalJune 21, 2026

Study on Predictors of PTSD Relapse in Children and Families

This study aims to identify clinical and neuropsychological markers that may predict PTSD relapse in children and their families.

StrategyJune 21, 2026

FDA Grants AP Status for Risperidone ANDA077494 Submission

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Risperidone under application number ANDA077494.

ClinicalJune 19, 2026

NIMH Study on Brain Function in Pediatric Bipolar Disorder

The NIMH is conducting a study to investigate severe mood dysregulation in children aged 7-17, focusing on symptoms and brain changes.

ClinicalJune 18, 2026

ACT vs CBT Trial for Psychological Distress in HIV/AIDS Patients

A randomized controlled trial is underway comparing Acceptance and Commitment Therapy and Cognitive Behavioral Therapy in HIV/AIDS patients.

ClinicalJune 16, 2026

Ashwagen® shows efficacy in managing stress and anxiety in hypertensive patients

A Phase III trial demonstrated that Ashwagen® significantly reduced anxiety and stress markers in patients with hypertension.

ClinicalJune 11, 2026

Dapagliflozin vs Metformin for Antipsychotic-Induced Weight Gain in Clinical Trial

A clinical trial is underway to compare the effectiveness of dapagliflozin and metformin in managing weight gain from antipsychotic medications.

ClinicalJune 10, 2026

Study Compares PE Therapy, Pharmacotherapy, and Combination for PTSD in Veterans

A randomized trial will compare the effectiveness of Prolonged Exposure therapy, paroxetine, venlafaxine, and their combination in veterans with PTSD.

CompetitiveJune 10, 2026