Sarepta Therapeutics has received FDA authorization to resume shipments of its gene therapy Elevidys to ambulatory patients with Duchenne muscular dystrophy following a thorough investigation into safety concerns raised after three patient deaths this year. The FDA concluded the latest fatality, involving an 8-year-old Brazilian boy, was unlikely related to the therapy. Sarepta plans to continue the voluntary shipment pause for non-ambulatory patients while safety label updates are finalized in collaboration with regulators. This decision restores access for younger patients whose disease progression has not advanced, underscoring ongoing risk mitigation efforts amid complex gene therapy evaluations.