PDUFA – Talk Bio

FDA Pushes Back Agios’ Pyrukynd Thalassemia Decision to December

2 weeks ago talkbio0Tagged Agios, decision delay, Liver damage, PDUFA, Pyrukynd, REMS, Thalassemia, United States Food and Drug Administration

FDA; Agios; Pyrukynd; thalassemia; PDUFA; decision delay; REMS; hepatocellular injury

Cytokinetics Stock Soars After Positive Phase 3 Data as FDA Approval Decision for Aficamten Nears

2 weeks ago talkbio0Tagged Aficamten, Approved, Cytokinetics, Hypertrophic obstructive cardiomyopathy, PDUFA, Performance, REMS, United States Food and Drug Administration

Cytokinetics; Aficamten; FDA approval; Phase 3 trial; obstructive hypertrophic cardiomyopathy (oHCM); PDUFA date; REMS; stock performance

FDA Extends PDUFA Date for Regenxbio’s Hunter Syndrome Gene Therapy RGX-121

1 month 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

Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay

2 months ago talkbio0Tagged Application procedure, dosing, Eylea HD, IL31RA gene, Interval, PDUFA, Regeneron, Retinal Diseases, Supplement, United States Food and Drug Administration

Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases

FDA Delays Blenrep Decision, Challenging GSK’s Multiple Myeloma Comeback Plans

2 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

FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload

3 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 Leaders Anticipate Imminent Drug Approval Decisions

3 months ago talkbio0Tagged approvals, Drug Approval, Leadership, PDUFA, regulatory decision, United States Food and Drug Administration

FDA; drug approval; PDUFA date; regulatory decision; upcoming approvals; FDA leadership

FDA Delays Decision on Biohaven’s Troriluzole for Rare Disease, Plans Advisory Committee Review

4 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 Continue as Regulator Misses Review Date for GSKs Nucala

4 months ago talkbio0Tagged Chronic Obstructive Airway Disease, delays, GSK 's, Nucala, PDUFA, Target, United States Food and Drug Administration

United States Food and Drug Administration, Nucala, Chronic Obstructive Airway Disease, GSK ‘s, Target, delays, PDUFA

FDA delays decision date on Cytokinetics’ heart drug to year-end in unusual safety program back-and-forth

5 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