Following an FDA review, Sarepta Therapeutics resumed shipments of Elevidys® gene therapy to ambulant Duchenne muscular dystrophy (DMD) patients after a brief pause triggered by safety concerns. The FDA and Brazilian authorities concluded an 8-year-old patient’s death was unrelated to the therapy. Non-ambulant patients remain on hold pending further safety discussions, including potential black box warnings. Sarepta continues collaborative efforts with the FDA to update labeling and risk mitigation.