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

In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

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

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

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

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

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in young children.

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

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

FDA names outspoken Covid vaccine critic as the new vaccine chief Dr. Vinay Prasad was an outspoken critic of the FDA’s response to the pandemic, including the former vaccine chief, Dr. Peter Marks.

Vinay Prasad, MD, MPH, the newly appointed Director of the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), will deliver the keynote address.