Deferred – Talk Bio

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

2 weeks ago talkbio0Tagged Accelerated, Alfa, amendment, Approved, Biologics License Application, Clinical pharmacology discipline, Deferred, Denali, Mucopolysaccharidosis II, review extension, tividenofusp, United States Food and Drug Administration

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval

Sanofi’s MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review

1 month ago talkbio0Tagged Breakthrough Therapy, Bruton 's tyrosine kinase inhibitor, Deferred, GEMINI trial, HERCULES trial, Multiple Sclerosis, NDA, nrSPMS, PERSEUS trial, regulatory review, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; FDA delay; multiple sclerosis; nrSPMS; Bruton’s tyrosine kinase inhibitor; breakthrough therapy; HERCULES trial; GEMINI trial; PERSEUS trial; NDA; regulatory review

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

2 months ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

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

2 months ago talkbio0Tagged clemidsogene lanparvovec, Deferred, gene therapy, IDS gene, Infrequent, Mucopolysaccharidosis II, PDUFA, Regenxbio, RGX-121, United States Food and Drug Administration

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

3 months ago talkbio0Tagged Blenrep, Deferred, Multiple Myeloma, Neoplasms, Ocular Toxicity, PDUFA, regulatory hurdles, SmithKline Beecham, United States Food and Drug Administration

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

4 months ago talkbio0Tagged ACIP, Advisory Committees, Bill Cassidy, Centers for Disease Control and Prevention (U.S.), Confirmation, Deferred, HELP Committee, Policy, RFK Jr., Senate, Vaccines

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

4 months ago talkbio0Tagged Angioedemas, Hereditary, constraints, Deferred, Drug Approval, KalVista, on-demand, Oral cavity, PDUFA, Resources, Sebetralstat, United States Food and Drug Administration

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

5 months ago talkbio0Tagged Advisory Committees, Ataxia, Spinocerebellar, Biohaven, Deferred, disease drug, Extension, Infrequent, Neurodegenerative Disorders, PDUFA, Troriluzole, United States Food and Drug Administration

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

6 months ago talkbio0Tagged Cytokinetics, Deferred, Evaluation, Extension, Hypertrophic obstructive cardiomyopathy, Mitigation Strategy, oHCM, PDUFA, Regulatory Setback, REMS, Risk, United States Food and Drug Administration

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

7 months ago talkbio0Tagged Approved, COVID19 (disease), Deferred, Maker (occupation), Market, Novavax 's, United States Food and Drug Administration, Vaccines

Vaccines, Approved, COVID19 (disease), United States Food and Drug Administration, Market, Novavax ‘s, Maker (occupation), Deferred