FDA Adds Strongest Warning to Sarepta Gene Therapy for Duchenne’s Linked to 2 Patient Deaths

US narrows use of muscle-wasting therapy after teen deaths

The United States on Friday said it would add its most serious warning label to a gene therapy treatment for a debilitating muscle-wasting disease, and also limit its approved use.

Gene Therapy Gets FDA's Strongest Warning After Fatal Liver Injuries

(MedPage Today) -- The FDA added a boxed warning to delandistrogene moxeparvovec (Elevidys) gene therapy for Duchenne muscular dystrophy and changed the indication of the drug after reports of fatal liver injury emerged, the agency announced Friday...

FDA adds strongest warning to Sarepta gene therapy for Duchenne’s linked to 2 patient deaths

The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year.

FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury

Silver Spring, Md., Nov. 14, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced it is taking action to approve new labeling...

Celebrating a new, faster path to gene-editing medicines on demand

Fyodor Urnov, an expert on gene-editing medicine, examines a new pathway for CRISPR treatments on demand — and deems it scientifically sound.