Despite regulatory setbacks, the petitioners believe that survival and other data they've collected themselves are worth ...

Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

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.