A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make ...

An FDA advisory committee unanimously recommended Thursday that the next COVID vaccine should be a monovalent one in the JN.1 ...

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

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

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

The advisory committee, which met after the agency rolled out new vaccine guidelines, said companies should tailor their ...

The vaccine eligibility change is a threat to the health of Americans, some experts say, adding that the FDA is not being ...

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

The FDA will now require clinical trials to approve boosters for healthy Americans under 65, making it unlikely the shots ...

Despite an explanation of the new strategy published Tuesday from FDA Commissioner Marty Makary and Vinay Prasad, who ...

The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk ...