The FDA plans advisory committee meetings in July 2026 for Replimune's RP1 melanoma therapy and Capricor's Deramiocel therapy for Duchenne muscular dystrophy.
Replimune's RP1 has an August 2, 2026, decision date with a late‑July advisory panel meeting expected.
Capricor's Deramiocel BLA will be reviewed by the Cellular, Tissue, and Gene Therapies Advisory Committee on July 29, 2026, with an August 22, 2026, PDUFA action date.
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