Sarepta Therapeutics said it has temporarily suspended shipments of Elevidys® (delandistrogene moxeparvovec-rokl) for infusion in non-ambulatory patients following the second death in three months of ...

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

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.

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 ...

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 ...

The FDA’s accelerated approval pathway plays a vital role, and scrapping it or reversing course on already-approved therapies ...

When two of medicine’s most outspoken reformers publish a roadmap for the FDA, you expect at least coherence. Instead, we get a curious blend of tech evangelism, selective evidence, and lofty ...