Duchenne Muscular Dystrophy

FDA granted four DMD antisense oligonucleotide accelerated approvals on ~1 percentage-point dystrophin increases. With $967M in annual revenue on...

FDA's CTGTAC voted 9-3 against Capricor's deramiocel on July 30, 2026. The science wasn't the problem. The statistical methodology...

FDA's July 27 briefing document for Deramiocel (BLA 125842) contradicts Capricor's Phase 3 efficacy claims ahead of tomorrow's AdCom...