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

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

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

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

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

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

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 ...

Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after ...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

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

Moderna has withdrawn its pending application for a combination vaccine for both the flu and Covid-19, saying it will resubmit later this year once it has more data.

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