FDA Approves Elevidys with Stricter Labeling

Sarepta Therapeutics Elevidys gene therapy receives FDA approval with restricted use, following reports of fatal liver failures in non-ambulatory patients. The updated labeling includes a Boxed Warning, weekly liver function tests, and a study to further investigate liver injury risks.The Daily News Now! — Every city. Every story. AI-powered. Hosted on Acast. See acast.com/privacy for more information.