US FDA adds strongest warning to Sarepta gene therapy after fatal liver injuries

Core Insights - The U.S. Food and Drug Administration has approved new labeling for Sarepta Therapeutics' gene therapy Elevidys, which now includes the most serious safety warning [1] - The use of Elevidys is restricted to walking patients diagnosed with Duchenne muscular dystrophy [1] Company Summary - Sarepta Therapeutics' gene therapy Elevidys has received updated labeling from the FDA [1] - The new labeling emphasizes significant safety concerns associated with the treatment [1] Industry Summary - The approval of new labeling by the FDA reflects ongoing regulatory scrutiny in the gene therapy sector [1] - The restriction of Elevidys usage to a specific patient group indicates a trend towards more cautious application of gene therapies in clinical settings [1]