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- FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy reviewThe FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a content…
- Curium seeks FDA review of rival radioligand therapy to boost supply resilience against Novartis' PluvictoCurium is preparing to challenge Novartis' dominant prostate cancer radioligand therapy, Pluvicto, by entering discussions with the FDA about reviewing its own PSMA‑directed Lu‑177 candidate. Nova…