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News

FDA, Sarepta and Gene therapy

Associated Press News on MSN · 2d
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 therapy.
Devdiscourse · 7h
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 requests, allowing the company to finalize the safety labeling process for the product.
Reuters on MSN · 3d
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died,
BioPharma Dive
6h
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" ...
21hon MSN
Sarepta extends losses premarket after refusing FDA’s halt request
Sarepta Therapeutics (SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second ...

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