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FDA to Ask Sarepta to Stop Shipping Muscular Dystrophy Drug Elevidys

The New York TimesFriday, July 18, 2025 at 11:01:45 PM
NegativeHealthpharmaceuticals
FDA to Ask Sarepta to Stop Shipping Muscular Dystrophy Drug Elevidys
The FDA is reportedly urging Sarepta Therapeutics to halt shipments of its muscular dystrophy drug, Elevidys, following the deaths of three patients who experienced liver failure after taking the treatment or a similar therapy. Elevidys is a one-time gene therapy designed to slow the progression of Duchenne muscular dystrophy, a severe muscle-wasting disease.
Editor’s Note: This is a big deal because Elevidys was seen as a promising treatment for a devastating condition with limited options. The deaths raise serious safety concerns, and the FDA’s move signals potential regulatory trouble ahead. For families affected by Duchenne, it’s another setback in the long search for effective therapies.
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