January - March 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting ...
ELEVIDYS (delandistrogene moxeparvovec-rokl) Hepatotoxicity-associated fatalities in non-ambulatory patients with Duchenne muscular dystrophy FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on June 24, 2025: FDA …