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The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from ...
The move follows the death of two teenagers who were administered the treatment, as well as the death of a 51-year-old ...
The drastic cost-cutting move follows the deaths of two teenagers that forced the company to restrict usage of its gene therapy for Duchenne muscular dystrophy.
The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.
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