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Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
Sarepta Therapeutics’ stock slips further as company bows to FDA pressure to halt shipments
Sarepta Therapeutics shares were lower in premarket trading on Tuesday, as the drugmaker relented to a Food and Drug ...
Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...
FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
Sarepta under pressure: FDA requests halt of Elevidys shipments
Sarepta Therapeutics (SRPT) stock is in focus after the US Food and Drug Administration (FDA) asked the company to halt ...
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Sarepta Therapeutics Temporarily Halts Elevidys Shipments in Compliance with FDA Requests
Sarepta Therapeutics Inc has voluntarily paused shipments of Elevidys in the United States. The decision responds to FDA ...
Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...
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FDA asks Sarepta to stop shipping Duchenne gene therapy
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
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For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak
As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are ...
BioPharma Dive3d
Sarepta stops Elevidys shipments after standoff with FDA
Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" ...
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Roche halts some shipments of Sarepta’s Duchenne gene therapy outside U.S.
Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid ...
Sarepta tells FDA it won’t halt shipments despite patient deaths
In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...