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

The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning ...

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

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.

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

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

The mRNA vaccines were developed using novel technology that was approved for the first time for public use during the COVID-19 pandemic.

Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after ...

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

Some members of the Vaccines and Related Biologics Products Advisory Committee worried that a strain change would require new ...

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

FDA now requires Pfizer and Moderna COVID-19 vaccines to carry expanded warning labels about risks of myocarditis and pericarditis ...