PDUFA
FDA Delays Decision on Sanofi’s Oral Multiple Sclerosis Drug to December 2025
FDA action date; Sanofi; tolebrutinib; multiple sclerosis; BTK inhibitor; nrSPMS; drug review delay; December 2025; PDUFA
FDA Pushes Back Agios’ Pyrukynd Thalassemia Decision to December
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
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
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