Extension
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 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 rejection of extended dosing interval is another piece of bad news for Regenerons Eylea HD
United States Food and Drug Administration, Interval, Regeneron, dosing, Extension, Eylea HD, rejection, Age related macular degeneration, Diabetic Retinopathy
Dexcom extends G7 sensor wear time to 15 days with latest FDA nod
United States Food and Drug Administration, sensor (device), Continuous glucose monitoring, MSH5 gene, Accurate (qualifier), Extension, wear time, day
FDA Approves Extended Dosing for Astellas’ Izervay, Intensifying Competition in Geographic Atrophy Treatment
Izervay, Astellas, FDA approval, extended dosing, geographic atrophy, age-related macular degeneration, Syfovre, Apellis, eye treatment
FDA Approves Extended Dosing for Astellas’ Izervay in Geographic Atrophy Treatment
Izervay, avacincaptad pegol, geographic atrophy, age-related macular degeneration, FDA approval, extended dosing, Astellas Pharma
Regeneron’s EYLEA HD Succeeds in Phase 3 Trial for Retinal Vein Occlusion, Paving Way for 2025 FDA Submission
EYLEA HD, Aflibercept, Retinal Vein Occlusion (RVO), Phase 3 QUASAR Trial, Extended Dosing Intervals, FDA Submission 2025, Regeneron Pharmaceuticals
Pfizer Expands API Manufacturing Site in Singapore with $740M+ Investment
Pfizer, API manufacturing, Singapore, facility extension, investment
Ascendis Hormone Replacement Therapy Faces Setback with FDA Review Extension
Ascendis Pharma, hormone replacement therapy, FDA review, delay, three-month extension.
Extended FDA Review Timeline for Ascendis’ Hormone Therapy
Ascendis Pharma, hormone therapy, FDA review, delay, 3 months extension.