PDUFA
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
Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay
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
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
KalVista Pharmaceuticals; sebetralstat; FDA delay; hereditary angioedema; resource constraints; PDUFA date; drug approval; oral on-demand treatment
FDA Leaders Anticipate Imminent Drug Approval Decisions
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
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
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
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
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
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