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FDA disputes Capricor Phase 3 trial results for Duchenne muscular dystrophy treatment
STAT NewsLO·US·1 day ago
An FDA advisory committee is reviewing the efficacy and safety data for Capricor Therapeutics' Duchenne muscular dystrophy drug, a process marked by prior regulatory contention. The committee's recommendation will significantly influence the FDA's final approval decision, which remains uncertain due to debate over clinical trial endpoints.