Sarepta FDA Request - Search News

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Gene Therapy Stays on Market Despite FDA Request

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 the agency was investigating the three deaths due to acute liver failure following treatment with Sarepta's AAVrh74 gene therapies.

· 2d · on MSN

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

Axios on MSN · 10h

Drugmaker refuses FDA request to pull gene therapy

Columbus Dispatch19h

Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy

The Food and Drug Administration announced the move, confirming an earlier Reuters report, after making the request at a meeting with Sarepta on July 18. After the FDA request, Cambridge, ...

Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

Sarepta Stock Keeps Sliding as Company Rejects FDA Call to Withdraw Drug

Sarepta Therapeutics has rejected a call by the Food and Drug Administration to stop shipments of its muscular dystrophy drug ...

1hon MSN

Sarepta Stock Sinks. How Its Crisis Went From Bad to Worse.

Sarepta stock has tanked. Most investors don’t see the drugmaker’s executive management as credible following the failure to disclose a patient death, a BMO survey suggests.

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