The FDA has reversed a previous recommendation and now allows Sarepta Therapeutics to resume shipments of its gene therapy Elevidys to ambulatory patients with Duchenne muscular dystrophy. This decision follows an investigation into the death of an 8-year-old boy in Brazil, which Brazilian authorities found unrelated to the treatment. Sarepta agreed to pause shipments temporarily after previous patient deaths linked to Elevidys. Shipments remain paused for non-ambulatory patients pending further discussions between Sarepta and the FDA regarding safety labeling and risk mitigation. Sarepta's CEO expressed commitment to working collaboratively with the FDA for patient safety and therapy availability.