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Sarepta Will Resume Gene Therapy Shipments

Bloomberg on MSN · 2h

FDA’s Vinay Prasad Exits After Sarepta Gene Therapy Controversy

Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his handling of Sarepta Therapeutics Inc.’s gene therapy.

Associated Press News on MSN · 10d

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy.

Reuters on MSN · 1d

Sarepta resumes shipping of gene therapy Elevidys to patients who can walk

Sarepta Therapeutics said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, sending the company's shares 59% higher in extended trading.

FDA Does 180 on Sarepta, Freeing DMD Gene Therapy for Ambulatory Patients

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

10h

FDA Lifts Safety Hold On Sarepta's Muscular Dystrophy Gene Therapy—Wall Street Cheers

Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.

15h

Sarepta: SRPT Stock To $40?

This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

4don MSN

Sarepta fails to win EU backing for muscle disorder gene therapy

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...

News Nation on MSN1d

Parents urge FDA to restore gene therapy after distribution pause

A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.

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