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STAT5h
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 ...
BioSpace1h
Following Sarepta’s Lead, Roche Suspends Elevidys Shipments to Some Ex-US Countries
Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...
Roche pauses shipments of Elevidys gene therapy outside US
Roche Holding AG said on Tuesday it has paused all shipments of muscular disorder gene therapy Elevidys outside the U.S., ...
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 ...
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and ...
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 ...
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 ...
Devdiscourse1d
Sarepta Suspends Gene Therapy Shipments After Tragic Deaths
Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular ...
Managed Healthcare Executive1d
Sarepta to Pause Shipments of the Gene Therapy Elevidys
Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...
BioPharma Dive1d
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...
Exclusive-US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy ...
STAT1d
In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.