Capricor's Duchenne therapy faces delayed FDA decision due to additional data review
The FDA has extended its review period for Capricor's deramiocel, a Duchenne muscular dystrophy treatment, to examine additional data for a more specific patient population. The company announced the PDUFA date delay on Monday, pushing back the expected decision.
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Original headline: “FDA delays Capricor's deramiocel PDUFA date to review new data.” Browse more stories.