United States, Nov. 14 -- The U.S. Food and Drug Administration announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency's most prominent safety warning, to Elevidys (delandistrogene moxeparvovec-rokl), and that the indication section of the labeling limits the therapy's indication to ambulatory patients four years of age and older with Duchenne muscular dystrophy (DMD). These actions follow reports of fatal acute liver failure in non-ambulatory patients treated with the product. Elevidys is an AAVrh74 adeno-associated virus (AAV) vector-based gene therapy approved for the treatment of DMD in certain patients. In June 2025, the FDA issued a CBER Safety Communica...