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

Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter ...

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

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

Today vaccine maker Moderna announced it voluntarily pulled its licensing submission for the combination seasonal ...

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

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

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 ...

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

Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after ...

Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U.S. Food and Drug Administration (FDA), the ...