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

The FDA is forcing Pfizer and Moderna to expand warning labels about the risks of two forms of heart damage, myocarditis and ...

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 ...

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

The FDA may limit annual COVID-19 boosters to high-risk groups unless clinical trials prove benefits for healthy adults under 65. Pfizer is reviewing the plan, while officials call for more evidence ...

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

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

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

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