Roche has temporarily suspended new orders of Duchenne muscular dystrophy gene therapy Elevidys in several countries that depend on FDA approval, responding to safety concerns including liver injuries linked to patient deaths. The cessation affects markets relying on FDA authorization, while shipments continue in countries with independent approvals such as Brazil and Japan. Roche emphasized confidence in Elevidys's benefit for ambulatory patients and acknowledged the challenging impact on Duchenne communities awaiting treatment. Parallel with these moves, Sarepta Therapeutics confronts an arduous path to resume marketing amidst FDA scrutiny.