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Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside ...
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...
Shares of Sarepta Therapeutics fell as much as 8% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the ...
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from liver failure after taking it or a similar treatment.
The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.
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