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

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

The founder and former CEO of several pharmaceutical companies, Tidmarsh was tapped by FDA Commissioner Marty Makary, MD, MPH ...

BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the ...

Food and Drug Administration Commissioner Marty Makary said he has “no preconceived plans” to change the policies on ...

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

The FDA on Tuesday rejected a skin therapy from Replimune Group, suggesting a hardened stance on drug approvals under new ...

Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty ...

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

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

Sarepta decision to halt Duchenne treatment continues to frustrate families; FDA reinstate a quarter of DOGE cuts; Contract research organizations report higher than expected pharma and biotech Q2 ...

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