The FDA reversed a recent decision and authorized Sarepta Therapeutics to resume shipping its gene therapy Elevidys to ambulatory patients with Duchenne muscular dystrophy after concluding a reported death was unrelated to the treatment. Partial distribution resumed amid ongoing safety discussions, with shipments to non-ambulatory patients remaining paused as investigations continue. Sarepta is collaborating with the FDA on updating safety labels, including adding black box warnings addressing risks of acute liver toxicity associated with viral vectors used in the therapy.