Sarepta Gene Therapy Halt - Search News

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Sarepta, FDA and Gene therapy

The Columbus Dispatch on MSN · 5h

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 to ambulatory people but maintain a halt it implemented June 15 for non-ambulatory patients after reporting to the FDA a case of acute liver failure in a patient who could not walk.

Associated Press News on MSN · 3d

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.

The Boston Globe · 8h

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 request, which was issued Friday.

2hon MSN

In a reversal, Sarepta says it will pause shipments of gene therapy linked to deaths

By Zachary Stieber Contributing Writer In a reversal, the drugmaker Sarepta Therapeutics said July 21 it is stopping all ...

MedPage Today1d

Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths

The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...

Managed Healthcare Executive11h

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 ...

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