A top FDA appointee who doesn’t think patients can be trusted to make their own healthcare decisions.

Three patient deaths linked to gene therapies developed by Sarepta Therapeutics (SRPT) have drawn FDA scrutiny on the viral ...

The Revell family hoped a gene therapy could buy time for their sons, who have a rare and fatal disease. After two patients ...

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

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

F ood and Drug Administration Commissioner Marty Makary said he has “no preconceived plans” to change the policies on mifepristone, an abortion pill that ends pregnancy before 10 weeks, in an ...

The appointment of a seasoned pharmaceutical executive, George Tidmarsh, to run the FDA’s drug center underscores the ...

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.

For the best immunization policy, they argue, the U.S. should look to Europe. Marty Makary, the new FDA commissioner, and ...