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After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...
Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...
Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid ...
Sarepta (SRPT) paused shipments of its top-selling gene therapy drug after the US Food and Drug Administration (FDA) raised safety concerns tied to liver toxicity. Yahoo Finance Senior Reporter ...
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 ...
Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a ...
Sarepta will stop shipping its Duchenne muscular dystrophy gene therapy Elevidys following ongoing discussions with the FDA over safety labeling. The drugmaker said the pause, effective July 22, will ...
Roche Holding AG temporarily halted shipments of its muscular disorder gene therapy, Elevidys, outside the U.S., mirroring its U.S. partner Sarepta Therapeutics. The pause affects orders relying on ...
By Zachary Stieber Contributing Writer In a reversal, the drugmaker Sarepta Therapeutics said July 21 it is stopping all ...
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
Roche Holding AG paused all shipments of the controversial gene therapy Elevidys following a similar action by the embattled ...