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.

Reuters on MSN · 2d

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

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died,

Axios on MSN · 9h

Drugmaker refuses FDA request to pull gene therapy

An unusual public feud between the Food and Drug Administration and a maker of gene therapies for rare diseases could test the Trump administration's willingness to pull certain approved drugs from the market over safety concerns.

9mon 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.

3hon MSN

BMO's Kostas Biliouris: It will be challenging for the FDA to force a market withdrawal for Sarepta

Kostas Biliouris, BMO Capital Markets biotech analyst, joins CNBC's 'Squawk on the Street' to discuss the latest details on ...

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 ...

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