ENTITY
Gilead Withdraws Trodelvy for Bladder Cancer in US After Confirmatory Trial Failure
Gilead Sciences, Trodelvy, bladder cancer, urothelial carcinoma, FDA, accelerated approval, drug withdrawal
Supernus’ SPN-820 Shows Rapid Symptom Improvement in Major Depressive Disorder
Supernus Pharmaceuticals, SPN-820, Major Depressive Disorder (MDD), Rapid-Acting Depression Treatment, Clinical Trial Results
European Commission’s Reconsideration of Translarna’s Marketing Authorization: A Critical Turning Point for Duchenne Muscular Dystrophy Treatment
Translarna, Duchenne muscular dystrophy, European Commission, EMA, CHMP, conditional marketing authorization, drug approval, regulatory decisions
Novo Nordisk’s Alhemo Nears EU Approval: A Breakthrough in Haemophilia Treatment
Novo Nordisk, Alhemo, Haemophilia A and B, Inhibitors, European Medicines Agency (EMA), CHMP positive opinion, Subcutaneous prophylactic treatment, Concizumab
FDA Delays Decision on Full Approval for Amgen’s Lumakras and Intercept’s Ocaliva
FDA, PDUFA, Amgen, Intercept, Lumakras, Ocaliva, metastatic colorectal cancer, primary biliary cholangitis
Breakthroughs in RSV Prevention: Merck and Pfizer Report High Efficacy Rates
RSV prevention, Merck, Pfizer, clesrovimab, ABRYSVO, respiratory syncytial virus, monoclonal antibodies, vaccines
Merck’s RSV Antibody Clesrovimab Shows Promising Efficacy in Late-Stage Trial
Merck & Co., RSV antibody, Clesrovimab, Respiratory syncytial virus, Infant protection, Late-stage trial results
Merck’s Clesrovimab Shows Promising Results in Preventing RSV Disease and Hospitalizations in Infants
Clesrovimab, Respiratory Syncytial Virus (RSV), RSV Disease Prevention, Infant Health, Monoclonal Antibody, Clinical Trials, Merck & Co.
Baxter to Import 18,000 Tons of IV Fluids by Year-End Amid Ongoing Hurricane Recovery Efforts
Baxter International, IV fluid shortage, Hurricane Helene, North Carolina, importation plans, healthcare crisis
Terray Therapeutics Secures $120M Series B Funding to Advance AI-Driven Small Molecule Drug Development
AI-driven drug discovery, small molecule development, Terray Therapeutics, series B funding, biotechnology, pharmaceutical innovation.