The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway ...

While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...

FDA Commissioner Marty Makary faces declining staff morale as he remakes the agency.

During his remarks in a Senate hearing in May, Senator Jon Ossoff torched FDA Administrator Marty Makary over the Trump Administration's disastrous layoffs. Ossoff stated, "You said that, right?" ...

FDA Commissioner Marty Makary’s pledge to reexamine the safety of medication abortion isn’t just pointless — it’s dangerous.

All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D. “I'm proud to report that we're on track to meet all the PDUFA targets and that morale is ...

Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England Journal of Medicine on May 20 requiring a stronger evidence base for boosters ...

Marty Makary’s stewardship of the FDA will be key to the policy success of the Make America Healthy Again movement. Photo: drew angerer/Agence France-Presse/Getty Images ...

A nasal spray for treatment-resistant depression has delivered strong clinical results and rekindled investor hopes.

Smucker says goodbye to synthetic dyes in popular products by 2027, including jams, ice cream toppings, and Hostess snacks ...

Some of us believe in civil debate and discussion, even though Drs. Vinay Prasad, Marty Makary, and Jay Bhattacharya do not.