Deferred
FDA Delays Decision on Biohaven’s Troriluzole for Rare Disease, Plans Advisory Committee Review
Biohaven; FDA delay; troriluzole; spinocerebellar ataxia (SCA); rare disease drug; PDUFA extension; advisory committee; neurodegenerative disease
FDA delays decision date on Cytokinetics’ heart drug to year-end in unusual safety program back-and-forth
Cytokinetics, aficamten, FDA delay, PDUFA date extension, hypertrophic obstructive cardiomyopathy (oHCM), Risk Evaluation and Mitigation Strategy (REMS), regulatory setback
Novavaxs held-up approval package may signal warning for Covid vaccine makers
Vaccines, Approved, COVID19 (disease), United States Food and Drug Administration, Market, Novavax ‘s, Maker (occupation), Deferred
FDA Delays Decision on Merus’ Zenocutuzumab for NRG1+ Lung and Pancreatic Cancer
Zenocutuzumab, NRG1+ cancer, FDA delay, Merus, lung cancer, pancreatic cancer, bispecific antibody.
FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review
Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.