Sarepta Defies FDA Request to Halt Gene Therapy Shipments Despite Patient Deaths

Reported 1 day ago

Sarepta Therapeutics has decided not to comply with the FDA's request to stop shipments of its gene therapy Elevidys, following the death of three patients. This decision has raised concerns over the future availability of the treatment, which is the first approved in the U.S. for Duchenne's muscular dystrophy. Despite the FDA's regulatory powers, Sarepta claims that its scientific review shows no new safety issues and plans to continue providing the therapy for younger patients.

Source: YAHOO

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