Advisers to the FDA will debate if the virus has mutated enough since last winter to require a tweak to the formula.

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

U.S. Food and Drug Administration advisers unanimously recommended on Thursday that COVID-19 vaccines for the 2025-26 period ...

Top U.S. vaccine regulator Vinay Prasad and FDA Commissioner Marty Makary, both of whom have been critical of U.S. COVID ...

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels ...

If COVID-19 leaked from a Chinese lab as a result of U.S.-funded gain-of-function research, is Donald Trump to blame? The New ...

Trump administration to restrict COVID vaccines to seniors and high-risk groups, pending more data for everyone else.

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

Mayoral candidate Adrienne Adams paid tribute to her military vet father — who died from COVID-19 — while ripping rival ex-Gov. Andrew Cuomo’s handling of the pandemic and ...

FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.