Tag Archives: Duchenne

FDA to ask Sarepta to stop shipping Duchenne gene therapy

FDA to ask Sarepta to stop shipping Duchenne gene therapy

The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive. Sarepta last month paused shipments for certain older Duchenne patients following the death from acute liver failure of a second teenager treated with the therapy, called Elevidys. The …

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