Sarepta ELEVIDYS Shipments Halted - Search News

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FDA, Sarepta and Elevidys

The Columbus Dispatch on MSN · 10h

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 · 1d

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.

BioPharma Dive · 1d

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" with the regulator.

12h

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 ...

pharmaphorum18h

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 ...

Managed Healthcare Executive15h

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 ...

Roche Pauses Shipments of Muscular Disorder Gene Therapy Elevidys Amid Safety Concerns

Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a ...

4don MSN

FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...

GEN - Genetic Engineering and Biotechnology News1d

About Face: Sarepta to Pause Elevidys Shipments Temporarily

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

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