Decision
FDA to Decide on Merck’s Subcutaneous Keytruda in September 2025
Subcutaneous Keytruda, FDA decision, September 23, 2025, Merck & Co., cancer treatment, PDUFA date
Australia steadfast on rejection of Eisai, Biogen’s Alzheimer’s therapy Leqembi
Lecanemab, Eisai, Leqembi, Alzheimer ‘s disease, Decision, Presenile dementia, Australia
FDA Delays Decision on Stealth BioTherapeutics’ Elamipretide for Barth Syndrome Until April 2025
Barth Syndrome, Elamipretide, FDA Decision, Stealth BioTherapeutics, Drug Approval Delay
Novartis CEO Reveals Strategic Pipeline Reduction by 40% Based on Data-Driven Insights
Novartis, clinical pipeline, data-driven decisions, pharmaceutical industry, strategic reduction
Lilly and J&J Unveil Promising IL-23 Inhibitor Data for Crohn’s Disease, Setting Stage for FDA Decisions
Crohn’s disease, IL-23 inhibitors, Eli Lilly, Johnson & Johnson, Omvoh, Tremfya, clinical trials, FDA decisions.
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
AstraZeneca and Daiichi Sankyo’s Dato-DXd Fails to Meet Overall Survival Goal in NSCLC Study, FDA Decision Looms
AstraZeneca, Daiichi Sankyo, Dato-DXd (datopotamab deruxtecan), Non-small cell lung cancer (NSCLC), Overall survival (OS), FDA decision, TROPION-Lung01 study
European Court Suspends EC’s Decision to Revoke Ocaliva’s Marketing Authorization
Ocaliva, European Court, EC decision, marketing authorization, primary biliary cholangitis, PBC, Advanz Pharma
Jazz Pharmaceuticals Presents Groundbreaking HER2 Biliary Tract Cancer Data Ahead of FDA Decision
Jazz Pharmaceuticals, HER2, Biliary Tract Cancer, FDA Decision, Zanidatamab, Priority Review
Extended Data from Gilead’s PBC Program Strengthens Case Ahead of FDA Ruling
Gilead, PBC Program, FDA Decision, Long-term Data, Primary Biliary Cholangitis