CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Since Dr. Vinay Prasad’s appointment as a key political voice within FDA, the tone of U.S. biotech policy has shifted from ...

After years of bashing the medical establishment, Drs. Vinay Prasad and Marty Makary are stuck in a trap. Any attempt to ...

Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.

We want to know more about what these products are doing,” said Dr. Vinay Prasad in a recent FDA livestreamed presentation. The statement is made as there has been a significant policy shift in the U.

The Health and Human Services chief and the growing authoritarianism within the department are already seeding future danger.

A series of recent changes could have significant implications for how Americans receive and pay for their shots.

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug review and speed up approval is not here yet.

While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...

FDA officials say the assistant is flawed, just as the Trump administration stresses AI adoption in healthcare.

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...