Sarepta FDA Regulatory Issues

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Sarepta, Duchenne and gene therapy

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency could still carry major consequences for the Duchenne community.

Precision Medicine Online · 1d

Sarepta Halts Duchenne Gene Therapy Sales Amid FDA Scrutiny, Raising Concerns Over Financial Future

· 20h

Sarepta Gets Thumbs Down From Regulators Regarding Elevidys Gene Therapy

Investor's Business Daily on MSN4d

Sarepta's 'Unprecedented Times' Continue As Company Rebukes The FDA

Sarepta stock took another dive Monday after the biotech company refused the FDA's request to voluntarily stop all shipments ...

Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty.

STAT5y

The FDA and Sarepta: A window into the world of drug regulation | STAT

The FDA's decisons about Exondys 51 and Vyondys 53, both developed by Sarepta Therapeutics, offer a rare glimpse into the world of drug regulation. Skip to Main Content FDA ...

FierceBiotech2y

FDA skips AdComm for Sarepta's DMD therapy, sets decision date

The FDA won’t be holding an advisory panel meeting for Sarepta Therapeutics’ SRP-9001, which is now that much closer to becoming the first gene therapy for Duchenne muscular dystrophy (DMD).

Yahoo8y

FDA confirms that critic of Sarepta drug has left the agency - Yahoo

An FDA spokeswoman would not say when Farkas left, and whether his departure is tied to the review for the Sarepta drug is not known. Farkas could not be reached for comment. But he has played a ...

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