Sarepta Therapeutics Inc. said a second patient has died of acute liver failure after being treated with its gene therapy for a rare muscle disorder.

Sarepta Therapeutics said it has temporarily suspended shipments of Elevidys® (delandistrogene moxeparvovec-rokl) for ...

Sarepta Therapeutics ( NASDAQ: SRPT) reported a second fatality from acute liver failure in a patient treated with its gene ...

Public health and infectious disease experts said they were surprised and confused about the move, and questioned why the HHS did not offer any reasoning for its decision.

The agency’s decision to clear Moderna’s shot for use in certain younger adults is a much-needed win for a company that’s ...

Novavax, Inc. faces profitability challenges despite a promising tech platform, with uncertain revenue streams. Click for my ...

Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the ...

In case you haven't had enough artificial intelligence, the US Food and Drug Administration is now outsourcing its oversight duties to a large language model (LLM.) In an article published in the ...

This story is from the next print edition of MIT Technology Review, which explores power—who has it, and who wants it. It’s ...

A new article in the Journal of the American Medical Association said the FDA will implement AI into multiple processes.

Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...