The FDA picked the LP.8.1 Covid strain for the fall vaccines, fueling concerns that the shots may be limited to only the most ...

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

Low uptake may reflect barriers—misinformation, access or shifting insurance coverage—not simply waning need.

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

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

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

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