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FDA Will Ask Sarepta to Halt Gene Therapy Shipments
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BioCentury first reported the patient death, which then prompted the FDA to request Sarepta to halt shipments of Elevidys, its Duchenne muscular dystrophy drug. Sarepta refused. That shocked ...
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from ...
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
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