Deferred
FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues
FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval
FDA Extends PDUFA Date for Regenxbio’s Hunter Syndrome Gene Therapy RGX-121
FDA delay; PDUFA extension; Regenxbio; Hunter syndrome; clemidsogene lanparvovec; RGX-121; gene therapy; Mucopolysaccharidosis II; IDS gene; rare disease
FDA Delays Blenrep Decision, Challenging GSK’s Multiple Myeloma Comeback Plans
FDA delay; Blenrep; GSK; multiple myeloma; regulatory hurdles; ocular toxicity; PDUFA; oncology; relapsed/refractory
Sen. Bill Cassidy Calls for Deferral of CDC Vaccine Meeting After RFK Jr. Panel Shakeup
Bill Cassidy; RFK Jr.; CDC; vaccine advisory committee; ACIP; confirmation; deferral; Senate HELP Committee; vaccine policy
FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload
KalVista Pharmaceuticals; sebetralstat; FDA delay; hereditary angioedema; resource constraints; PDUFA date; drug approval; oral on-demand treatment
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.