source
- Researchers concerned by underutilization of accelerated approval in oncologyMost adult cancer drugs approved by the US Food and Drug Administration (FDA) over the past two decades were regular approvals for expanded indications based on surrogate endpoints, rather than acc…raps · 1d ago↗ source
- FDA unveils FY 2027 user fee ratesThe US Food and Drug Administration (FDA) has published its user fee rates for FY 2027 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. Th…raps · 1d ago↗ source
- FDA advisory panel votes 9-3 against Capricor's Duchenne therapy deramiocelDuring an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting, reviewers focused on the Phase 3 HOPE-3 trial's secondary cardiac endpoint and described the data as very fragile. The…