By Bhanvi Satija (Reuters) -The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy Elevidys, a source familiar with the ...

Sarepta says it informed the agency of the third patient's condition — life-threatening acute liver failure — on June 20. Then, the company notified the FDA of the patient's death on July 3.

Drugmaker Sarepta Therapeutics said it won’t comply with a request from the FDA to halt all shipments of its gene therapy following the death of a third patient receiving one of its treatment… ...

Sarepta Therapeutics traded lower on Monday, extending a slide as the company took the unusual step of refusing a Food and Drug Administration request to stop selling a drug tied to three deaths.

Sarepta Therapeutics shares traded lower in premarket trade on Tuesday, as the drugmaker relented to a Food and Drug Administration request to halt the shipments of a gene therapy.

Inside an FDA drug rejection, and layoffs at Sarepta By Allison DeAngelis, Adam Feuerstein, and Elaine Chen July 17, 2025 ...

The FDA is set to decide whether to approve the drug, called Blenrep, as soon as next week. GSK was trying to revive the drug, which was pulled from the U.S. market in 2022 after failing a late ...

FDA asks Sarepta to stop shipping gene therapy after patient deaths. Sarepta says no. expand Sarepta CEO Douglas Ingram JASON GROW By Hannah Green – Reporter, Boston Business Journal Jul 18 ...

WASHINGTON — Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of ...

The FDA said Friday it placed that trial on hold. Sarepta noted that the gene therapy involved in the incident uses “a different dose and is manufactured using a different process,” than Elevidys.

WASHINGTON (AP) — Drugmaker Sarepta Therapeutics said late Friday it won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the ...