The U.S. FDA revised the label for Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys, adding a boxed safety warning and limiting use to ambulatory patients, and requested postmarketing study commitments. The agency’s action follows ongoing safety and physician concern discussions about the therapy’s risk profile. Sarepta must now implement restricted use criteria and undertake additional postmarketing surveillance to better characterize long‑term safety. The move reflects regulatory emphasis on narrow, risk‑mitigating labeling when serious safety signals or clinical uncertainties remain. For clinicians and payers, the change clarifies which patient populations are considered appropriate for Elevidys and raises operational considerations for centers administering one‑time gene therapies, including monitoring and risk‑management plans.