EMA Decision

FDA Accepts Supplement Application for Injectafer (Ferric Carboxymaltose)

The FDA has accepted the supplemental application for Injectafer (ferric carboxymaltose) submitted by AM REGENT.

FDA grants priority review for Bristol Myers Squibb's Iberdomide NDA221075

The FDA has granted priority review for Bristol Myers Squibb's New Drug Application (NDA) for Iberdomide (ZENBEXUS) for the treatment of multiple myeloma.

Novartis initiates Phase 3 trial of Pelabresib plus Ruxolitinib in Myelofibrosis

Novartis is conducting Phase 3 trial to assess the efficacy of Pelabresib combined with Ruxolitinib in patients with myelofibrosis who have not received prior JAK inhibitor therapy.

Phase I trial of BEBT-507 for Polycythemia Vera initiated by BeBetter Med Inc.

BeBetter Med Inc. has initiated a multicenter, open-label Phase I trial of BEBT-507 in subjects with polycythemia vera, focusing on safety, tolerability, pharmacokinetics, and preliminary efficacy.

FDA Approval Status for Eltrombopag Olamine by Hikma

The FDA has granted an approval status of 'AP' for Hikma's ANDA220033 application for Eltrombopag Olamine, a treatment for thrombocytopenia. This application is currently in the regulatory approval phase, with a standard review priority.

Quinacrine Trial for Cutaneous Lupus Erythematosus Underway

A clinical trial is currently evaluating the safety and efficacy of quinacrine in treating cutaneous lupus erythematosus (CLE), with a total participation duration of 28 weeks.

FDA accepts ANDA for Semaglutide by Apotex Inc.

The FDA has accepted the ANDA application number 220314 for Semaglutide submitted by Apotex Inc. under standard review.

Novartis initiates study on nilotinib treatment-free remission in CML patients

Novartis is conducting a study to evaluate the safety of suspending nilotinib treatment in CML patients who have achieved optimal response.

Study on mNGS for Diagnosing Invasive Fungal Disease in Hematological Malignancies

A single-center, open-label study is underway to evaluate the clinical performance of peripheral blood mNGS for diagnosing invasive fungal disease in patients with hematological malignancies.

FKC289 Phase I/II Study Initiated for Relapsed/Refractory AL Amyloidosis

Shenzhen Fosun Kairos Biotechnology Co., Ltd. has initiated Phase I/II clinical study to evaluate FKC289 in patients with relapsed/refractory primary AL amyloidosis, focusing on safety and efficacy.

GE HealthCare Issues Recall for Carestations Due to Ventilation Risk in VCV Mode

GE HealthCare is recalling certain Carestations due to a risk of ineffective ventilation in Volume Control Ventilation mode, indicated by alarms, while other modes remain effective.

Study on Belantamab Mafodotin and Lenalidomide in Newly Diagnosed Multiple Myeloma

A clinical trial is underway to evaluate the efficacy of belantamab mafodotin combined with lenalidomide as maintenance therapy in newly diagnosed multiple myeloma patients post-autologous hematopoietic cell transplantation.

Chengdu Zenitar initiates Phase IIa trial of Flonoltinib for polycythemia vera patients resistant to standard therapies

Chengdu Zenitar Biomedical Technology is conducting Phase IIa trial of Flonoltinib Maleate in patients with polycythemia vera who are resistant or intolerant to hydroxyurea or interferon.

Pfizer and Valneva's Lyme Disease Vaccine MAA Validated by EMA

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, a 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate developed by Pfizer and Valneva.

Merck initiates trial of Bomedemstat vs Best Available Therapy in Essential Thrombocythemia

Merck Sharp & Dohme LLC is conducting a study to evaluate bomedemstat (MK-3543) against best available therapy in patients with essential thrombocythemia who have not responded adequately to hydroxyurea.

Novo Nordisk Tests New Oral Semaglutide D in Type 2 Diabetes Study

Novo Nordisk is conducting a 27-week clinical trial to evaluate the safety and efficacy of oral semaglutide D, a new formulation, compared to the already approved oral semaglutide in Japanese patients with type 2 diabetes.

FDA grants accelerated approval to iberdomide with daratumumab for multiple myeloma

The FDA has granted accelerated approval to iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy.

Feasibility Study on Digital Tool for Chronic Myeloid Leukemia Patient Monitoring

Versailles Hospital is conducting a feasibility study to evaluate a digital monitoring tool for chronic myeloid leukemia patients who have discontinued treatment for up to 2 years. The study will assess the tool's usage rates over a 12-month period, with a threshold of 60% for feasibility.

FDA Accepts Supplement for SAPHNELO (Anifrolumab) by AstraZeneca

The FDA has accepted the supplemental biologics application (BLA761123) for SAPHNELO (anifrolumab) from AstraZeneca.

FDA Accepts Supplemental NDA for Ozempic (Semaglutide) by Novo

The FDA has accepted the supplemental NDA for Ozempic (semaglutide), submitted by Novo, with a standard review priority.

Phase II Trial of ASTX727 with Iadademstat in Advanced Myeloproliferative Neoplasms

A phase II trial is evaluating the efficacy of ASTX727 combined with iadademstat versus ASTX727 alone in patients with advanced Philadelphia chromosome negative MPNs.

FDA Approval Process for PHYTONADIONE by AMNEAL

The FDA is reviewing ANDA217734 for PHYTONADIONE submitted by AMNEAL, with a standard review priority.

BST-236 evaluated in adults with relapsed or refractory AML or HR-MDS

A clinical trial sponsored by Groupe Francophone des Myelodysplasies is evaluating the efficacy and safety of BST-236 as a single agent in adults with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (HR-MDS) who are unfit for intensive chemotherapy.

Phase I Trial of JL19001 Injection in Advanced Solid Tumors and B-NHL Initiated by Jecho Biopharmaceuticals

Jecho Biopharmaceuticals has initiated Phase I trial to evaluate JL19001 Injection in patients with advanced solid tumors and relapsed/refractory B-NHL, focusing on safety and tolerability.

Phase 1a/1b trial of SG301 for relapsed/refractory multiple myeloma initiated by Hangzhou Sumgen Biotech

Hangzhou Sumgen Biotech has initiated Phase 1a/1b clinical trial to evaluate SG301 in patients with relapsed or refractory multiple myeloma and other hematological malignancies.

Phase 3 Study of Rocbrutinib vs Pirtobrutinib in R/R CLL/SLL Initiated by Newave Pharmaceutical

Newave Pharmaceutical Inc.

Phase 1/2 Study of JNJ-88549968 in CALR-Mutated Myeloproliferative Neoplasms

A clinical trial is underway to evaluate the safety and dosing of JNJ-88549968 for CALR-mutated myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis.

IcoSema Study Compares Weekly Insulin Icodec/Semaglutide to Daily Insulin Glargine in T2D

A clinical trial is currently evaluating IcoSema, a weekly combination of insulin icodec and semaglutide, against daily insulin glargine in patients with type 2 diabetes whose blood sugar levels are inadequately controlled by oral medications.

NCI Launches Study on Tailored Stem Cell Transplantation for RUNX1 Blood Cancers

The National Cancer Institute (NCI) has initiated a prospective trial to assess the efficacy of tailored chemotherapy and supportive care in stem cell transplantation for patients with blood cancers linked to germline RUNX1 mutations.

Phase II Trial of Tovorafenib (DAY101) for Relapsed/Refractory Langerhans Cell Histiocytosis

A phase II trial is currently evaluating the safety, tolerability, and efficacy of tovorafenib (DAY101) in patients with progressive, relapsed, or refractory Langerhans cell histiocytosis.

FDA Accepts Supplement for FERAHEME by AZURITY

The FDA has accepted a supplemental application for FERAHEME (ferumoxytol) submitted by AZURITY, with a standard review priority.

Study Evaluates MCV Test for Phlebotomy Therapy in Hemochromatosis Patients

A clinical trial is currently evaluating the effectiveness of the Mean Corpuscular Volume (MCV) test in comparison to the ferritin test for guiding phlebotomy therapy in patients diagnosed with hemochromatosis.

FDA Grants Approval for Phytonadione ANDA215820 by Dr. Reddy's

The FDA has granted approval for Dr. Reddy's ANDA215820, which contains phytonadione as the active ingredient.

Abemaciclib Trial Initiated for Dedifferentiated Liposarcoma

A clinical trial is underway to evaluate the efficacy of Abemaciclib in patients with dedifferentiated liposarcoma, a condition where the drug has not been previously tested.

Launch of Natural History Study for Niemann-Pick Disease Type C to Build Comprehensive Database

A new natural history study aims to establish the first and largest genomic and phenotypic database for Niemann-Pick Disease Type C.

Impact of Dexamethasone Duration on AL Amyloidosis Treatment Outcomes

The study highlights the uncertainty surrounding the optimal duration of dexamethasone in treating newly diagnosed AL amyloidosis, especially with the introduction of daratumumab-based regimens.

NCI Trial Evaluates New Drug Combo for GVHD Prophylaxis in HIV Patients Undergoing Bone Marrow Transplant

A trial is underway to assess the safety and efficacy of a new drug combination for preventing graft-versus-host disease in HIV-positive patients undergoing bone marrow transplantation.

Study on Genetic Factors in Patients with Low Von Willebrand Factor Levels Initiated

The LOVMIC Study aims to explore genetic factors contributing to low von Willebrand factor levels, addressing gaps in current understanding.

Study on Vaccine Response to HZ/su in SLE Patients Compared to Controls

This observational study aims to assess the vaccine response to HZ/su in patients with systemic lupus erythematosus (SLE) compared to matched controls.

NCI Trials Mirdametinib and Sirolimus in RAS Mutated Relapsed Refractory Multiple Myeloma

A clinical trial is underway to evaluate the safety and efficacy of mirdametinib and sirolimus in patients with RAS mutated relapsed refractory multiple myeloma.

Alvelestat (MPH966) Trial for Bronchiolitis Obliterans Syndrome Post-HSCT Initiated

A clinical trial is underway to evaluate the safety and efficacy of alvelestat (MPH966) in patients with bronchiolitis obliterans syndrome following hematopoietic stem cell transplantation.

Neoepitope-specific T Cell Therapy for Blood Cancers Enters Clinical Trials

A clinical trial is underway to evaluate the efficacy of autologous T cells modified to target neoepitopes in patients with blood cancers.

Phase II Study of Elranatamab in Outpatients with Relapsed/Refractory Multiple Myeloma

The study aims to assess the incidence of cytokine release syndrome during the first treatment cycle of elranatamab in RRMM patients.

FDA Submission Update for Ruxolitinib by Apotex

Apotex has submitted New Drug Application (NDA) for Ruxolitinib under application number NDA219660.

FDA Accepts BLA761147 for PEGFILGRASTIM-PCCG by Accord Biopharma

The FDA has accepted the Biologics License Application for BLA761147, PEGFILGRASTIM product from Accord Biopharma.

Semaglutide (Wegovy) Under Investigation for Trichotillomania Treatment

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

Study on Familial Platelet Disease with RUNX1 Variants Launched

A longitudinal study has been initiated to investigate familial platelet disease (FPD) associated with RUNX1 variants.

FDA Accepts Supplement Application for Wegovy (Semaglutide) by Novo

The FDA has accepted a supplemental application for Wegovy (semaglutide), indicating ongoing development and potential label expansion.

Deucravacitinib Shows Promise in Treating Psoriasis with Eczematous Features

A study is evaluating the efficacy and safety of deucravacitinib in patients with Psoriasis Eczema (PsEma) over 16 weeks.

FDA Accepts Supplement Application for Wegovy (Semaglutide) by Novo

The FDA has accepted a supplemental application for Wegovy (semaglutide) submitted by Novo.

Gene Therapy for Sickle Cell Disease Shows Promising Safety and Efficacy in 36 Patients

An expanded access protocol for a gene therapy targeting BCL11A in sickle cell disease has shown increased fetal hemoglobin levels without unexpected safety issues in 36 patients.

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.

FDA Submission Update for ANDA220421 by Hetero Labs

The FDA has received an application (ANDA220421) from Hetero Labs for Vemagal, currently under standard review.

Study on Digital Support Impact on Multiple Myeloma Patient Quality of Life

A prospective study is underway to evaluate the effectiveness of a personalized web-based platform on the quality of life for multiple myeloma patients.

FDA Approves JAKAFI XR (Ruxolitinib Phosphate) Submission by Incyte

The FDA has approved the New Drug Application (NDA) for JAKAFI XR, a formulation of ruxolitinib phosphate, submitted by Incyte Corporation.

Phase 1 Study of Tomivosertib in Relapsed/Refractory AML Initiates Dose Finding

A Phase 1 trial for tomivosertib in relapsed or refractory acute myeloid leukemia is set to begin, utilizing Bayesian optimal interval dose finding design.

Efgartigimod shows potential as maintenance therapy for iTTP in pilot study

A pilot study indicates that efgartigimod may effectively increase ADAMTS13 activity in patients with iTTP, potentially preventing relapses.

Safety and Feasibility Study of CD34+ Stem Cells in RUNX1 Familial Platelet Disorder

A study is underway to assess the safety and feasibility of mobilizing and collecting autologous CD34+ hematopoietic stem cells in patients with RUNX1 familial platelet disorder.

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.

Evaluation of LumiraDx D-Dimer Assay for VTE Diagnosis

The study assesses the accuracy of the LumiraDx D-Dimer assay in diagnosing venous thromboembolism.

Study on Predictive Factors for Thromboembolic Events in High-risk Polycythemia Vera

A prospective observational study is set to enroll 150 patients with high-risk Polycythemia Vera to identify predictive factors for thromboembolic events.

Asciminib Efficacy in Real-World CML Patients in Second-Line Treatment Assessed

An observational study is underway to evaluate the efficacy and tolerability of asciminib in real-world settings for CML patients in second or subsequent lines of treatment.

FDA Submission for Ruxolitinib by Apotex Receives Standard Review Status

Apotex has submitted New Drug Application for Ruxolitinib under NDA219660, which is currently under standard review.

Safety and Tolerability Study of Dapirolizumab Pegol in Systemic Lupus Erythematosus

A study is underway to evaluate the long-term safety and tolerability of dapirolizumab pegol in patients with systemic lupus erythematosus.

FDA Approves Eltrombopag Olamine Application by Biocon Pharma

The FDA has approved the application ANDA220660 for Eltrombopag Olamine submitted by Biocon Pharma.

EUGIA PHARMA's Tranexamic Acid Supplement Receives FDA AP Status

EUGIA PHARMA's application for a supplement of Tranexamic Acid has received FDA approval status.

HPV Vaccine Hesitancy Among Female Students in China Increases Despite Improved Knowledge

HPV vaccine hesitancy among female university students in China rose from 8.8% to 21.6% between 2022 and 2025, despite improved knowledge.

CCR7(low) Treg Subset Linked to Poor Prognosis in B-ALL

The study identifies a correlation between a highly suppressive CCR7(low) Treg subset and poor prognosis in B-ALL.

European Commission Approves Pfizer-BioNTech XFG-adapted COVID-19 Vaccine for 2026-2027

The European Commission has granted marketing authorization for the Pfizer-BioNTech XFG-adapted COVID-19 vaccine for individuals 6 months and older.

FDA Approves Lenalidomide Supplement by Zydus Pharmaceuticals

The FDA has approved a supplemental application for lenalidomide submitted by Zydus Pharmaceuticals.

FDA Approves Lenalidomide ANDA217554 Submission by Deva Holding AS

The FDA has approved the ANDA217554 submission for Lenalidomide by Deva Holding AS.

Study on Erythropoietin's Impact on Hepcidin Levels in Healthy Volunteers

This study aims to assess how intravenous erythropoietin affects serum and urinary hepcidin levels.

Mezagitamab Study Initiated for Chronic Primary Immune Thrombocytopenia

A clinical trial is underway to evaluate the efficacy of mezagitamab in stabilizing platelet counts in adults with chronic primary immune thrombocytopenia compared to placebo.

Emavusertib + Zanubrutinib Study Targets CLL Anticancer Activity

The study aims to evaluate the anticancer activity of emavusertib combined with zanubrutinib in CLL patients.

FDA Accepts Supplemental Application for REVLIMID by Bristol Myers Squibb

The FDA has accepted a supplemental application for REVLIMID (lenalidomide) submitted by Bristol Myers Squibb.

FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.

The FDA has licensed Ezplaz Freeze Dried Plasma, the first of its kind in the U.S., for transfusion in adults.

Regeneron initiates study on linvoseltamab for high-risk monoclonal gammopathy

Regeneron Pharmaceuticals is conducting a proof-of-concept study to evaluate linvoseltamab's efficacy in eliminating abnormal plasma cells in patients at risk of multiple myeloma.

Cipla's Lenalidomide ANDA213165 Receives AP Status from FDA

Cipla's application for lenalidomide has received an Abbreviated Approval (AP) status from the FDA.

Novo Nordisk Initiates Post-Marketing Surveillance for Alhemo® in Haemophilia Patients

Novo Nordisk is conducting a post-marketing surveillance study on Alhemo® to assess its safety and effectiveness in real-world settings.

Long-term Outcomes of Transplantation vs Standard Care in Sickle Cell Anemia Assessed

An observational study is being conducted to reevaluate long-term cerebrovascular outcomes in sickle cell patients post-transplantation.

FDA Accepts Supplemental Application for REVLIMID by Bristol Myers Squibb

The FDA has accepted a supplemental application for REVLIMID (lenalidomide) from Bristol Myers Squibb.

Ultomiris Phase III trial fails to meet primary endpoint in HSCT-TMA

Ultomiris did not achieve statistical significance for event-free survival in HSCT-TMA patients compared to placebo.

Trial on HBM-Based Education for ROP Screening in Premature Infants' Parents

A clinical trial is assessing the effectiveness of HBM-based educational interventions on ROP screening knowledge among parents.

Novartis initiates long-term safety study for ruxolitinib and panobinostat combination

Novartis is conducting a long-term safety study for patients previously treated with ruxolitinib or its combination with panobinostat.

Study on FLT3 Inhibitors' Immunological Impact Post-HSCT in AML Patients

A study is underway to evaluate the immunological effects of Gilteritinib and other FLT3 inhibitors in AML patients post-allogeneic stem cell transplantation.

FDA Accepts Supplement for RYTELO (Imetelstat Sodium) by Geron

The FDA has accepted a supplemental application for RYTELO (Imetelstat Sodium) submitted by Geron.

Merck's Bomedemstat Trial for Polycythemia Vera Aims to Improve Treatment Outcomes

Merck is conducting a clinical trial to evaluate the efficacy of bomedemstat compared to standard treatments for polycythemia vera.

Isatuximab Evaluated in Stem Cell Transplant for Multiple Myeloma and Lymphoma

A clinical trial is investigating the effects of Isatuximab on the immune system during stem cell recovery in multiple myeloma and lymphoma patients.

Lenalidomide being studied for treatment of adult histiocyte disorders

A clinical trial is investigating Lenalidomide for treating Langerhans cell histiocytosis, Erdheim-Chester disease, and histiocytic sarcoma.

NCI Launches Study on Myelodysplastic Syndromes to Enhance Treatment Options

The National Cancer Institute is conducting a comprehensive study on the natural history of MDS and MDS/MPN, aiming to collect biological samples for better treatment development.

Study Compares Semaglutide, Surgery, and Lifestyle for Weight Management in Endometrial Cancer

The study evaluates the effectiveness of sleeve gastrectomy, semaglutide, and a lifestyle program for weight management in endometrial cancer patients.

Blood Sampling Study for Sickle Cell Disease Research Initiated by NIDDK

A study has been launched to collect blood samples from individuals with unique red blood cell features related to sickle cell disease.

MHRA Issues Guidance on Safe Use of GLP-1 Weight Loss Medicines

The MHRA emphasizes the importance of safe usage of GLP-1 medicines amid rising demand for weight-loss solutions.

Study on 18F-Fluciclovine PET/CT for Improved Detection in Multiple Myeloma

A clinical trial is underway to evaluate the efficacy of 18F-fluciclovine PET/CT compared to 18F-FDG in detecting multiple myeloma.

Long-Term Study of DISC-1459 for EPP Shows Safety and Efficacy Potential

The study is designed to evaluate the safety, tolerability, and efficacy of DISC-1459 in patients with EPP.

CHMP recommends EU approval of Roche’s Susvimo for neovascular AMD

The CHMP has recommended the approval of Susvimo, a continuous delivery treatment for neovascular AMD, based on positive clinical trial data.

CHMP recommends EU approval of Roche’s Susvimo for nAMD treatment

The CHMP has recommended the approval of Susvimo, a continuous delivery treatment for nAMD, based on clinical trial data.

Memantine Pilot Study for Cognitive Protection in Pediatric Brain Tumor Patients Undergoing Radiation

A pilot study is underway to evaluate memantine as a neuro-protective agent in children receiving cranial radiation therapy for localized brain tumors.

AstraZeneca Initiates Phase 1b/2 Trial of AZD0120 for Relapsed/Refractory Multiple Myeloma

AstraZeneca is conducting Phase 1b/2 trial of AZD0120, a dual CAR T-cell therapy targeting CD19 and BCMA, in patients with relapsed/refractory multiple myeloma.

FDA Accepts Supplemental NDA for VONJO (Pacritinib Citrate)

The FDA has accepted a supplemental NDA for VONJO, JAK inhibitor, indicating progress in its regulatory pathway.

FDA Accepts Supplement for JAKAFI (Ruxolitinib Phosphate) by Incyte

The FDA has accepted a supplemental application for JAKAFI, JAK inhibitor developed by Incyte.

FDA Approves Supplemental Application for INREBIC (Fedratinib Hydrochloride)

The FDA has approved a supplemental application for INREBIC, a treatment for myelofibrosis.

FDA Grants Approval for Ferric Carboxymaltose by Mylan

The FDA has granted approval for Ferric Carboxymaltose under application ANDA217769 submitted by Mylan.

FDA Grants Approval for Ferric Carboxymaltose by Mylan Labs

The FDA has granted approval for Ferric Carboxymaltose under application ANDA212572 submitted by Mylan Labs.

FDA Approves Ferric Carboxymaltose for Mylan's ANDA217076

The FDA has approved Mylan's application for Ferric Carboxymaltose under ANDA217076.

FDA Accepts Supplemental Application for NEUPOGEN by Amgen

The FDA has accepted a supplemental application for NEUPOGEN (filgrastim) from Amgen, indicating ongoing development.

Agios initiates trial of mitapivat in pediatric PKD patients with no transfusion history

Agios Pharmaceuticals is conducting a trial to assess mitapivat's efficacy and safety in pediatric patients with PKD who are not regularly transfused.

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.

FDA Approves Supplemental Application for PURIXAN by Nova Labs

The FDA has approved a supplemental application for PURIXAN, an antimetabolite containing mercaptopurine, submitted by Nova Labs.

FDA Grants Priority Review for Novartis' Fabhalta (Ipacopan Hydrochloride)

The FDA has granted priority review status for Novartis' NDA for Fabhalta, containing ipacopan hydrochloride.

Study on Engineered Dendritic Cell Vaccines for Multiple Myeloma Initiated

A clinical trial is underway to assess the feasibility, safety, and efficacy of engineered dendritic cell vaccines for multiple myeloma.

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.

FDA Accepts Supplement Application for Verzenio (Abemaciclib)

The FDA has accepted a supplemental application for Verzenio (abemaciclib) from Eli Lilly.

Roche Reports Strong H1 2026 Sales and Multiple FDA Priority Reviews

Roche's H1 2026 sales increased by 6% at constant exchange rates, driven by strong demand for innovative medicines. The FDA granted Priority Reviews for five key therapies, including giredestrant for breast cancer and Enspryng for thyroid eye disease.

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.

Study on C1q-Binding HLA Antibodies and Platelet Transfusion Response

A clinical trial is investigating the effectiveness of C1q-binding HLA antibodies in predicting platelet transfusion responses in thrombocytopenic patients.

JNJ-79635322 Dose Escalation Study in Multiple Myeloma Shows Promising Combinations

The study aims to establish recommended Phase 2 doses for JNJ-79635322 in combination with daratumumab and other agents.

CAR-T Cell Therapy for ALL: Emerging Research Trends and Focus Areas Identified

A bibliometric analysis reveals a significant growth in CAR-T cell therapy research for acute lymphoblastic leukemia, with a focus on long-term outcomes and risk assessment.

FDA Accepts Supplemental Application for Ozempic (Semaglutide)

The FDA has accepted a supplemental application for Ozempic, GLP-1 agonist developed by Novo Nordisk.

FDA Grants Approval for Amneal's Phytonadione ANDA217734

The FDA has granted approval for Amneal's Abbreviated New Drug Application for Phytonadione.

Faron Pharmaceuticals Initiates Phase IIb Trial of Bexmarilimab in Higher-risk Myelodysplastic Syndromes

Faron Pharmaceuticals is conducting Phase IIb trial (BEXERA) to evaluate bexmarilimab combined with azacitidine in treatment-naïve higher-risk MDS patients.

Phase 1 Trial of VAS-101 Gel for Improved Curcumin Absorption in Sickle Cell Disease

A clinical trial is underway to evaluate the efficacy of VAS-101, a skin gel containing curcumin, in patients with stable sickle cell disease.

Lilly to acquire Ajax Therapeutics for myelofibrosis and polycythemia vera

Lilly is acquiring Ajax Therapeutics to enhance its portfolio in treating myelofibrosis and polycythemia vera, leveraging Ajax's lead program, AJ1-11095, a first-in-class Type II JAK2 inhibitor.

FDA Accepts Supplement for FERAHEME by AZURITY

The FDA has accepted a supplemental application for FERAHEME, an iron replacement therapy.

Eli Lilly's LY3457263 Trial in Type 2 Diabetes Shows Potential Against Semaglutide and Tirzepatide

Eli Lilly is conducting a trial to evaluate LY3457263 against placebo in type 2 diabetes patients on semaglutide or tirzepatide.

FDA Grants AP Status for Dr. Reddy's PHYTONADIONE ANDA215820

The FDA has granted Abbreviated Approval (AP) status for Dr. Reddy's ANDA215820 for PHYTONADIONE.

AstraZeneca's AZD0120 Phase I Study in Multiple Myeloma Initiated

AstraZeneca has initiated Phase I study to evaluate the safety and tolerability of AZD0120 in multiple myeloma patients.

Teva's Eltrombopag Olamine ANDA209938 Receives Approval

Teva Pharmaceuticals has received approval for their ANDA209938 application for Eltrombopag Olamine.

Trial on Respiratory Training in Lower Extremity Lymphedema Initiated by Toros University

A randomized controlled trial is underway to assess the impact of respiratory and relaxation training on patients with lower extremity lymphedema.

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.

FDA Accepts Supplemental Application for Verzenio (Abemaciclib)

The FDA has accepted a supplemental application for Verzenio, CDK4/6 inhibitor developed by Eli Lilly.

University of Missouri Initiates Study on Lymphatic Pain and Lymphedema Management

A new clinical trial aims to implement digital assessments and self-care interventions for lymphatic pain and lymphedema in breast cancer patients.

CPAP Trial Aims to Reduce Bronchopulmonary Dysplasia in Premature Infants

The CPAP Trial is evaluating the impact of prolonged CPAP use on reducing bronchopulmonary dysplasia or death in preterm infants.

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.

Biogen's Litifilimab (BIIB059) Study Targets Active Cutaneous Lupus Erythematosus

Biogen is conducting a 2-part clinical trial to evaluate the efficacy and safety of litifilimab in patients with active cutaneous lupus erythematosus.

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.

Ionis Pharmaceuticals Evaluates Sapablursen in Polycythemia Vera Patients

Ionis Pharmaceuticals is conducting a study to assess the efficacy of sapablursen in reducing phlebotomy frequency and improving quality of life in polycythemia vera patients.

FDA Approves Supplemental Application for Wegovy (Semaglutide)

The FDA has approved a supplemental application for Wegovy, a drug containing semaglutide, submitted by Novo.

Hetero Labs submits ANDA220421 for Vemagal with standard review priority

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

FDA Approves JAKAFI XR for Incyte Corp.

The FDA has approved JAKAFI XR, a formulation of ruxolitinib phosphate, for use.

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.

Safety Assessment of Propranolol for Infantile Hemangiomas Highlights Cardiovascular Risks

Real-world assessment of propranolol treatment for infantile hemangiomas indicates potential cardiovascular side effects.

UCB's Dapirolizumab Pegol Shows Promise in Systemic Lupus Erythematosus Study

A study is underway to evaluate the efficacy and safety of dapirolizumab pegol as an add-on treatment for moderately to severely active systemic lupus erythematosus.

Phase II Trial of Nemtabrutinib with CAR T-cell Therapy in Relapsed/Refractory CLL/SLL

A phase II trial is investigating the efficacy of combining nemtabrutinib with lisocabtagene maraleucel in patients with relapsed/refractory CLL/SLL.

Phase II Study of Allogeneic Stem Cell Transplant for VEXAS Syndrome Initiated

A Phase II clinical trial is underway to evaluate the efficacy of allogeneic hematopoietic stem cell transplant in patients with VEXAS Syndrome.

FDA Approves Isatuximab-irfc Subcutaneous Injection for Multiple Myeloma

The FDA has approved isatuximab-irfc for subcutaneous administration in multiple myeloma.

Natural History Study of MBL and CLL/SLL to Identify Disease Progression Markers

A natural history study is being conducted to investigate the clinical and molecular aspects of MBL, CLL/SLL, and related lymphomas.

Novartis initiates tolerability study of ianalumab with TPO-RA in ITP patients

A new study is assessing the tolerability of ianalumab combined with investigator's choice TPO-RA in ITP patients.

Elranatamab shows robust efficacy and favorable safety in relapsed/refractory multiple myeloma

Elranatamab is a bispecific antibody approved for relapsed/refractory multiple myeloma, demonstrating a favorable safety profile and robust efficacy.

MHRA Reviews Safety of Five Plasma-Derived Products for vCJD Risk

The MHRA has completed a review of five plasma-derived medicinal products regarding their safety related to vCJD risk.

MHRA Approves UK Plasma Donations for Key Medicinal Products

The MHRA has approved the use of UK-donor plasma for five high-priority plasma-derived medicinal products.

Study Comparing Single-Dose vs Divided-Dose G-CSF for Stem Cell Mobilization

A clinical trial is underway to compare the efficacy of single-dose versus divided-dose G-CSF in healthy stem cell donors.

FDA Grants Priority Review for KISQALI FEMARA Co-Packaged Product

The FDA has granted priority review for the co-packaged product KISQALI FEMARA, which includes letrozole and ribociclib succinate.

NCI Study to Collect Samples for Hairy Cell Leukemia and Immunotoxin Development

The National Cancer Institute is collecting samples from leukemia patients and healthy volunteers to study hairy cell leukemia and develop immunotoxins.

Long-term follow-up study on hematopoietic stem cell transplantation and therapies

A long-term follow-up study is being conducted to assess the effects of hematopoietic stem cell transplantation, cellular therapy, and gene therapy on patients and donors.

FDA Approval Status for Tranexamic Acid by Micro Labs

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Tranexamic Acid submitted by Micro Labs.

Risk of Severe Harm from Incorrect Blood Transfusion Administration Sets

Using an IV infusion giving set instead of a blood transfusion giving set poses a risk of serious harm to patients.

AstraZeneca's Anifrolumab Study for Systemic Lupus Erythematosus Underway

AstraZeneca is conducting a study to evaluate the pharmacokinetics, pharmacodynamics, and safety of anifrolumab in patients with systemic lupus erythematosus.

AstraZeneca Investigates Safety of Ondexxya IV Injection in Real-World Use

AstraZeneca is conducting a survey to assess the safety and effectiveness of Ondexxya IV Injection 200 mg in real-world conditions.

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.

Economic Review of Nirmatrelvir/Ritonavir for COVID-19 Health Outcomes

The systematic literature review evaluates health-related outcomes of nirmatrelvir/ritonavir treatment for COVID-19.

FDA Grants Approval for Mylan's Ferric Carboxymaltose ANDA217076

The FDA has granted approval for Mylan's Abbreviated New Drug Application (ANDA) for Ferric Carboxymaltose.

Study to Enhance Hydroxyurea Adoption for Sickle Cell Disease in Nigeria

A study aims to improve hydroxyurea adoption for sickle cell disease in Nigeria, addressing significant provider-level barriers.

Phase Ib/II Trial of Sonrotoclax and BCMA Bispecific Antibody in Systemic AL Amyloidosis

A phase Ib/II trial is evaluating sonrotoclax plus dexamethasone in newly diagnosed systemic AL amyloidosis patients based on t(11;14) genetic stratification.

Catch-up vaccination safe and effective in children with Kaposiform hemangioendothelioma on sirolimus

Catch-up vaccinations in children with Kaposiform hemangioendothelioma treated with sirolimus were safe and immunogenic.

Teclistamab Combination Study in Multiple Myeloma Initiated by Janssen

A new clinical trial is underway to evaluate the safety and tolerability of teclistamab in combination with other anticancer therapies for multiple myeloma.

Wrist-Ankle Acupuncture Shows Promise for Preventing Postoperative Nausea in High-Risk Patients

A randomized controlled trial evaluated the efficacy of wrist-ankle acupuncture for preventing postoperative nausea and vomiting in high-risk female patients.

FDA Grants Approval for Biocon's Eltrombopag Olamine under ANDA220660

The FDA has granted approval for Biocon Pharma's ANDA220660 for Eltrombopag Olamine.

Eugia Pharma's Tranexamic Acid Supplement Application Receives AP Status from FDA

The FDA has granted an Abbreviated New Drug Application (ANDA) AP status for Eugia Pharma's Tranexamic Acid.

Janssen initiates rollover study for long-term safety in multiple cancers

Janssen is conducting a rollover study to gather long-term safety data for participants with various cancers.

Telerehabilitation vs Face-to-Face Care in Hemophilia Patients: A Comparative Study

A randomized controlled trial is assessing the effectiveness of telerehabilitation compared to face-to-face care for adults with hemophilia and chronic pain.

Pacritinib trial for Myelodysplastic Syndromes in adults and children initiated by NCI

A clinical trial is underway to evaluate pacritinib in patients aged 12 and older with Myelodysplastic Syndromes (MDS) and MDS/MPN.

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.

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.

FDA Acceptance of Supplemental NDA for REVLIMID by Bristol Myers Squibb

The FDA has accepted a supplemental NDA for REVLIMID (lenalidomide) submitted by Bristol Myers Squibb.

Gerofit Exercise Intervention Study for Sickle Cell Disease Shows Promise

The SICKLE-FIT study aims to evaluate a personalized exercise program for older adults with sickle cell disease.

FDA Accepts BLA for Anifrolumab by AstraZeneca

The FDA has accepted the Biologics License Application for Anifrolumab, a treatment for systemic lupus erythematosus.

Study on Eczema Treatments and Skin Bacteria Launches

A new clinical trial is investigating the effects of eczema treatments on skin bacteria in patients with moderate to severe atopic dermatitis.

Lisaftoclax Evaluated for Preventing Differentiation Syndrome in APL Patients

A clinical trial is underway to evaluate the efficacy and safety of Lisaftoclax in preventing differentiation syndrome in patients with acute promyelocytic leukemia receiving ATRA/ATO treatment.

AstraZeneca initiates Phase I/II trial of AZD9829 for CD123+ hematological malignancies

AstraZeneca is conducting Phase I/II trial to evaluate AZD9829 in patients with CD123+ hematological malignancies.

Phase 2 Study of Ruxolitinib in Chronic Myelomonocytic Leukemia Shows Potential for Improved Outcomes

A Phase 2 expansion study is underway to evaluate the efficacy of ruxolitinib in patients with CMML.

Regeneron initiates trial for pozelimab + cemdisiran in PNH patients unresponsive to C5 inhibitors

Regeneron is conducting a study to evaluate the efficacy of pozelimab and cemdisiran in PNH patients inadequately controlled by existing therapies.

Semaglutide (Wegovy) approved for metabolic-associated steatohepatitis treatment

Semaglutide injection has received approval for the treatment of metabolic-associated steatohepatitis in adults with moderate-to-advanced liver fibrosis.

Eisai's E6742 Shows Promise in Systemic Lupus Erythematosus Study

E6742 is being evaluated for efficacy in systemic lupus erythematosus compared to placebo, with results expected at Week 24.

Eli Lilly initiates Phase 1 trial of oral IDH inhibitor LY3410738 in hematologic malignancies

Eli Lilly is conducting Phase 1 trial of LY3410738, targeting patients with IDH1 or IDH2 mutations in advanced hematologic malignancies.

Study on Risk Stratification in Infantile Hemangioma With Minimal Growth Initiated

A prospective observational study is underway to evaluate management strategies for infants with IH-MAG compared to classic hemangiomas.

Phase II/III Trial Evaluates Azacitidine with Lenalidomide or Vorinostat in Myelodysplastic Syndromes

A randomized phase II/III trial is investigating the efficacy of azacitidine combined with lenalidomide or vorinostat in patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia.

Modeling Hyperthermia-Enhanced Delivery of Doxorubicin in Solid Tumors

Mathematical modeling shows that timing hyperthermia with peak plasma TSL-DOX levels can double intracellular doxorubicin concentration.

FDA Accepts Supplement Application for RYTELLO (Imetelstat Sodium)

The FDA has accepted the supplemental application for RYTELLO, an imetelstat sodium product.

Phase I Trial of Pacritinib with Venetoclax and Azacitidine for Myeloproliferative Neoplasms

A Phase I trial is investigating the combination of pacritinib, venetoclax, and azacitidine for treating accelerated and blast phase myeloproliferative neoplasms.

GSK's Belantamab Mafodotin Study Targets Multiple Myeloma with Renal Impairment

A study is underway to evaluate the safety and pharmacokinetics of belantamab mafodotin in multiple myeloma patients with varying degrees of renal impairment.

FDA Approves Casgevy for Young Children with Sickle Cell Disease

The FDA has granted supplemental approval for Casgevy for young children with sickle cell disease and transfusion-dependent β thalassemia.

Novartis initiates pediatric study for asciminib in Chronic Myeloid Leukemia

Novartis is conducting a study to evaluate the dose and safety of asciminib in pediatric patients with Chronic Myeloid Leukemia.

FDA Accepts Supplement Application for BESREMI (Ropeginterferon Alfa-2b-NJFT)

The FDA has accepted the supplemental application for BESREMI, a treatment involving Ropeginterferon Alfa-2b-NJFT.

FDA Approves Ferric Carboxymaltose ANDA212572 by Mylan Labs

The FDA has approved the Abbreviated New Drug Application (ANDA) for Ferric Carboxymaltose submitted by Mylan Labs.

FDA Approves ANDA217769 for Ferric Carboxymaltose by Mylan

The FDA has granted approval for the Abbreviated New Drug Application ANDA217769 for Ferric Carboxymaltose submitted by Mylan.

FDA Approves Allogeneic T Cell Immunotherapy for Hematologic Malignancies

The FDA has approved a new allogeneic regulatory T cell-based immunotherapy for use in matched donor hematopoietic stem cell transplantation.

FDA Approves TREGZI for Chronic GVHD in Blood Cancer Patients

The FDA has approved TREGZI, the first Treg cell-based immunotherapy for chronic GVHD-free survival in blood cancer patients.

Phase 3 Trial of C1 Esterase Inhibitor for Acute Hereditary Angioedema by Octapharma

Octapharma is conducting a phase 3 trial of C1 esterase inhibitor concentrate for treating acute hereditary angioedema.

Phase 3 Trial of Navenibart for Hereditary Angioedema Initiated by Astria Therapeutics

Astria Therapeutics has initiated Phase 3 trial for navenibart in patients with hereditary angioedema.

Sex-based differences in TLR agonist efficacy for early-stage melanoma treatment

Intradermal delivery of TLR9 agonist CPG7909 shows sex-based differences in immune response, with men exhibiting superior dendritic cell maturation. TLR7/8 agonist resiquimod shows better activation in female patients.

FDA Drug Trials Snapshot: YARTEMLEA Approved for TA-TMA

YARTEMLEA has been approved for treating TA-TMA in patients aged 2 and older.

Trial Evaluating Levofloxacin for Infection Prophylaxis in MDS and AML Patients

A randomized controlled trial is assessing the safety and effectiveness of levofloxacin in reducing infection risk in MDS and AML patients undergoing outpatient chemotherapy.

FDA Approves Supplemental Application for AJOVY (Fremanezumab)

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

Microperimetry Predicts Outcomes in Diabetic Macular Oedema Treated with Anti-VEGF

Baseline microperimetry and metabolic status are predictive of functional outcomes in DME patients receiving anti-VEGF therapy.

Phase IIa Trial of Metformin for Preventing Oral Cancer in Premalignant Lesions

A phase IIa trial is investigating the efficacy of metformin hydrochloride in preventing oral cancer in patients with premalignant lesions.

Phase II Trial of MRD-Guided Zanubrutinib and Sonrotoclax in High-Risk CLL/SLL Patients

A phase II clinical trial is underway to evaluate the efficacy and safety of zanubrutinib combined with sonrotoclax in treatment-naïve high-risk CLL/SLL patients.

Lilly's Jaypirca recommended for EU approval in CLL across all therapy lines

The CHMP has issued a positive opinion for Lilly's Jaypirca (pirtobrutinib) for adults with CLL.

Study on Gynecological Complications Post Stem Cell Transplantation

A study is investigating the prevalence of gynecological complications in women after allogeneic hematopoietic stem cell transplantation.

Phase III Trial Compares Stereotactic Radiosurgery to HA-WBRT in Brain Cancer Patients

A phase III trial is underway to evaluate the efficacy of stereotactic radiosurgery versus hippocampal avoidance whole brain radiation therapy combined with memantine in patients with small cell lung cancer that has metastasized to the brain.

Study on Factors Regulating Mast Cell Proliferation in Mastocytosis

A study is being conducted to examine growth factors affecting mast cell proliferation in patients with mastocytosis.

JNJ-68284528 (cilta-cel) vs Standard Therapy in Multiple Myeloma Study Initiated

A study is underway comparing the efficacy of JNJ-68284528 (cilta-cel) against standard therapies in multiple myeloma.

IRON-DEP Study Evaluates IV vs Oral Iron for Postpartum Depression in Anemia

The IRON-DEP Study aims to compare the efficacy of intravenous and oral iron treatments on postpartum depression prevalence in women with moderate iron deficiency anemia post-caesarean.

Novartis conducts safety study of Iptacopan in PNH patients using registry data

Novartis is conducting a post-authorization safety study of Iptacopan in adult PNH patients using data from the IPIG PNH registry.

Phase I Trial of Lentiviral Gene Therapy for Hemophilia A Initiated

A Phase I trial is underway to evaluate the safety and efficacy of lentiviral gene therapy for hemophilia A.

Agios Pharmaceuticals' Mitapivat Shows Promise in Non-Transfusion-Dependent Thalassemia Study

A study is evaluating the efficacy and safety of mitapivat in patients with non-transfusion-dependent thalassemia.

mRNA-LNP Vaccine TP0435 Shows Promise Against Syphilis in Animal Models

The TP0435 mRNA-LNP vaccine demonstrated strong protective immunity against Treponema pallidum in rabbits, outperforming protein vaccines.

Study on APL-like Acute Myeloid Leukemia and Vascular Complications Initiated

A multicenter observational study is investigating the APL-like subset of acute myeloid leukemia as a predictor of coagulopathy and early vascular events.

FDA Grants Approval for Eltrombopag Olamine ANDA208815

The FDA has granted approval for ANDA208815, a generic version of Eltrombopag Olamine by Actavis Labs.

FDA Grants Approval for Fostamatinib Disodium ANDA217329

The FDA has granted approval for ANDA217329, a generic application for Fostamatinib Disodium submitted by Annora Pharma.

FDA Grants Priority Review for Pfizer's Marstacimab (BLA761369)

The FDA has granted priority review status for Pfizer's BLA761369, containing the active ingredient Marstacimab.

Phase I/II Trial of 211At-BC8-B10 in High-Risk Acute Leukemia and Myelodysplastic Syndrome

A phase I/II trial is evaluating the safety and dosing of 211At-BC8-B10 followed by donor stem cell transplant in patients with relapsed or refractory high-risk acute leukemia or myelodysplastic syndrome.

SBRT and IL-12 in PDAC: Local Therapy Alters Bone Marrow Hematopoiesis

Localized SBRT and IL-12 treatment in PDAC showed significant effects on bone marrow, including acute lymphopenia and altered hematopoiesis.

Development of Pediatric cGVHD Symptom Scale to Enhance Patient Reporting

A new questionnaire for assessing symptoms of chronic graft-versus-host disease in children/adolescents is being developed.

Semaglutide tablet approved in the UK for weight loss

The semaglutide tablet has received approval from the MHRA for weight loss and management in the UK.

Phase I/II Trial of Abemaciclib with Gemcitabine for Advanced Soft Tissue Sarcoma

A phase I/II trial is evaluating the safety and efficacy of abemaciclib combined with gemcitabine versus gemcitabine with docetaxel in patients with advanced soft tissue sarcoma.

FDA Grants Priority Review for Pfizer's Marstacimab (HYMPAVZI) Supplement

The FDA has granted priority review status for the supplemental application of Marstacimab (HYMPAVZI) by Pfizer.

FDA Accepts Supplement for AJOVY (Fremanezumab) by Teva Pharmaceuticals

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

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.

Venetoclax-Dexamethasone Trial for t(11;14) Relapsed/Refractory Amyloidosis Initiated

A clinical trial is underway to evaluate the safety and efficacy of venetoclax combined with dexamethasone for relapsed or refractory t(11;14) light chain amyloidosis.

Systematic review on EGFR alterations in recurrent glioblastoma therapy response

The review assesses the predictive value of EGFR amplification and EGFRvIII mutation for EGFR-targeted therapy in recurrent glioblastoma.

Study on Hemato-immunological Parameters in Immune Thrombocytopenic Purpura

A study is underway to identify hemato-immunological parameters that predict the chronicity of Immune Thrombocytopenic Purpura (ITP) and differences between pediatric and adult populations.

Guidance on Distinction Between Angioedema Types for ACE-Inhibitor Users

Healthcare professionals are advised about the delayed onset of angioedema and the differing treatment strategies for bradykinin- versus histamine-mediated cases.

Lilly to present positive Phase 3 results for pirtobrutinib in CLL at EHA 2026

Apotex Inc. Submits ANDA for Ruxolitinib

Apotex Inc. has submitted an Abbreviated New Drug Application (ANDA) for Ruxolitinib, indicating a move to enter the market.

FDA Proposes Exclusion of Semaglutide, Tirzepatide, and Liraglutide from 503B Bulks List

The FDA has proposed to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, indicating no clinical need for compounding these drugs.

FDA Lists Quinacrine Hydrochloride for Compounding in Cutaneous Lupus Erythematosus

Quinacrine is included on the FDA 503B list for compounding, indicating a clinical need for its use in treating cutaneous lupus erythematosus.

SillaJen initiates Phase 1 trial of BAL0891 in advanced solid tumors and AML

SillaJen is conducting Phase 1 trial of BAL0891, evaluating its safety and tolerability in advanced solid tumors and relapsed/refractory AML.

Nemtabrutinib Study vs Ibrutinib/Acalabrutinib in 1L CLL/SLL Initiated

A study is underway to evaluate nemtabrutinib against ibrutinib or acalabrutinib in treatment-naive CLL/SLL patients.

Phase III Trial of Hemay005 in Chinese Patients with Ulcerative Colitis Initiated

A phase III trial has been initiated to evaluate Hemay005 for the treatment of moderately to severely active ulcerative colitis in Chinese patients.

FDA Accepts Roche's Gazyva for Systemic Lupus Erythematosus Treatment

The FDA has accepted Roche's sBLA for Gazyva/Gazyvaro, based on phase III ALLEGORY data showing significant efficacy in SLE.

Roche Reports Strong Q1 2026 Sales Growth Driven by Innovative Medicines and Diagnostics

Roche's Q1 2026 sales grew 6% at constant exchange rates, driven by strong demand for innovative medicines, particularly in multiple sclerosis and oncology.

CVS Caremark to cover Foundayo and Zepbound, enhancing access for obesity treatment

CVS Caremark will cover Foundayo starting June 1 and Zepbound from October 1, allowing eligible patients to pay as low as $25 monthly.

Saphnelo Self-Administration Approved in the US for SLE Treatment

AstraZeneca's Saphnelo has received FDA approval for self-administration via a new autoinjector, enhancing patient convenience.

European Commission Approves Pfizer’s HYMPAVZI for Hemophilia A and B Treatment

The European Commission has approved HYMPAVZI for treating hemophilia A or B in patients 12 years and older with inhibitors, based on Phase 3 data showing significant bleed reduction.

Lilly's Foundayo shows superior A1C reduction and weight loss in pivotal diabetes trials

Foundayo (orforglipron) demonstrated a 57.1% greater reduction in A1C and significant weight loss compared to oral semaglutide in pivotal trials.

Lilly's Foundayo shows superior results in Phase 3 trial for type 2 diabetes

Phase 3 ACHIEVE results indicate Foundayo outperformed oral semaglutide and dapagliflozin in treating type 2 diabetes.

Merck's KEYTRUDA Plus Padcev Receives Positive EU CHMP Opinion for Muscle-Invasive Bladder Cancer

The EU CHMP has issued a positive opinion for the combination of KEYTRUDA and Padcev as a treatment for cisplatin-ineligible muscle-invasive bladder cancer.

Roche and Nurix Collaborate on BTK Degrader Bexobrutideg for B-cell Malignancies

Roche has entered a collaboration with Nurix Therapeutics to co-develop bexobrutideg, a novel BTK degrader targeting B-cell malignancies, immunology, and neurology.

Pfizer's LORBRENA CROWN Trial Reports Longest Progression-Free Survival in Advanced NSCLC

The seven-year analysis of the CROWN trial shows a 55% likelihood of remaining alive without disease progression for patients treated with LORBRENA, with median progression-free survival not reached.

Lilly's Jaypirca shows 45% reduction in disease progression risk in CLL/SLL

Jaypirca (pirtobrutinib) significantly reduced the risk of disease progression or death by 45% when added to a venetoclax regimen in previously treated CLL/SLL patients.

Lilly presents promising Phase 1 data for first-in-class type II JAK2 inhibitor in myelofibrosis

Lilly's AJ1-11095, a type II JAK2 inhibitor, shows an encouraging safety profile and promising clinical activity in myelofibrosis patients.

FDA Approves Pfizer’s HYMPAVZI for Expanded Hemophilia A and B Indications

The FDA has approved an expanded indication for Pfizer’s HYMPAVZI to treat hemophilia A or B in patients aged 6 and older, including those with inhibitors.

Enhertu recommended for EU approval in HER2+ metastatic solid tumours

Enhertu has been recommended for approval by the CHMP for patients with previously treated HER2-positive metastatic solid tumours.

Zhuochuming® Trial Evaluates 3+T&E vs 3+PRN in Diabetic Macular Edema

A clinical trial is underway to compare the efficacy of Zhuochuming® using a 3+T&E regimen against a 3+PRN regimen in treating treatment-naïve patients with diabetic macular edema.