PDUFA – Talk Bio

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

3 weeks 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

4 weeks 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

2 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

2 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

2 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

FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts

2 months ago talkbio0Tagged Agencies, Approved, Impact food supplement, PDUFA, questions, United States Food and Drug Administration

United States Food and Drug Administration, PDUFA, Impact food supplement, Approved, Agencies, questions

Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs

3 months ago talkbio0Tagged Biopharma regulatory issues, Budgets, delays, drug review, HHS layoffs, layoffs, Medical Devices, operational, PDUFA, regulatory, RFK Jr., United States Food and Drug Administration, user fee

FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions