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FDA, Sarepta and Elevidys

The Columbus Dispatch on MSN · 2d

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.

Fierce Pharma · 3d

Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm behind its approved Duchenne muscular dystrophy (DMD) treatment. | As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head,

Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, noting the need to maintain a good working relationship with the regulator.

Fierce Pharma5h

FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

8hon MSN

Sarepta Needs to Show FDA Elevidys Won’t Cause More Deaths

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...

2d

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 ...

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 ...

3don MSN

Sarepta’s Elevidys Halted at Children’s Hospital Los Angeles

Children’s Hospital Los Angeles paused the use of Sarepta Therapeutics Inc.’s gene therapy for Duchenne muscular dystrophy in ...

Sarepta Stands Ground Against HHS Request To Stop Elevidys Shipments

In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The ...

BioPharma Dive2d

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" ...

3don MSN

Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug Elevidys

Sarepta Therapeutics' (SRPT) stock continued to sink Tuesday following a rough end to last week, including a previously ...

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