FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers ...

Seven weeks into his job as FDA commissioner, Marty Makary, MD, MPH, held his own answering a barrage of sometimes ...

The hearing was supposed to focus on the Trump administration’s 2026 budget request, but instead covered a wide range of ...

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

Q: Did President Donald Trump call military nurse Ruby Bradley a “loser,” and were there orders for her service history to be removed from Department of Defense archives?

Government advisers are meeting Thursday to decide if COVID-19 vaccines need updating to improve protection this fall and ...

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

Before being confirmed as the head of the U.S. Food and Drug Administration (FDA) on March 25, Dr. Marty Makary was an influential critic of the medical establishment, targeting hospitals on patient ...

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain ...

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory ...

The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination ...

FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots ...