For Immediate Release: July 28, 2025 The U.S. Food and Drug Administration is recommending the removal of the voluntary hold for ambulatory patients who may now receive Elevidys, a Sarepta Therapeutics gene therapy for Duchenne Muscular Dystrophy (DMD). The FDA’s investigation has concluded that the death of the 8-year-old boy is unrelated to the gene therapy product itself . …
Read More »FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients
