The FDA may limit annual COVID-19 boosters to high-risk groups unless clinical trials prove benefits for healthy adults under ...

Key Takeaways Federal regulators have issued a warning about rare heart inflammation in young males after mRNA COVID ...

The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded ...

The notice came shortly after an advisory panel meeting at which members debated the pros and cons of asking manufacturers to ...

Advisers to the Food and Drug Administration met Thursday to help decide which variant of the virus that causes COVID should ...

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 ...

The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the ...

FDA COVID vaccine update is stirring major public attention as a new policy limits fall COVID-19 booster shots to seniors and ...

The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at ...

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

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...