source
- FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcommThe FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s Duchenne muscular dystrophy cell therapy.
- FDA warns investors that advisory panel reviews do not guarantee drug approval, cites concerns at Capricor and ReplimuneThe FDA issued a reminder to investors that the outcomes of advisory committee meetings are not final decisions on a drug’s fate. This week the agency released briefing documents highlighting conc…