Sarepta ELEVIDYS Shipments Halted - Search News

News

Sarepta, FDA and Elevidys

The Columbus Dispatch on MSN · 1d

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.

Devdiscourse · 2d

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.

Managed Healthcare Executive · 1d

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 while they address a safety labeling update about the risk of acute liver disease related to Elevidys.

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 ...

1d

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 ...

Fierce Pharma12h

Roche halts Elevidys distribution in some countries, following Sarepta's lead in US

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...

5don MSN

FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths

Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, ...

Sarepta backs down and pauses Elevidys shipments

The FDA appears to have won its staring contest with Sarepta over shipments of Elevidys, after the company blinked and agreed ...

GEN - Genetic Engineering and Biotechnology News2d

About Face: Sarepta to Pause Elevidys Shipments Temporarily

Sarepta Therapeutics said it will voluntarily “and temporarily” pause all shipments of Elevidys® (delandistrogene ...

Some results have been hidden because they may be inaccessible to you

Show inaccessible results