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 ...

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

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

Moderna had designs on releasing a combined influenza and covid-19 vaccine after some promising trials, but this week the ...

In another sign of growing scrutiny over Covid-19 vaccines, the Food and Drug Administration has asked the two makers of mRNA ...

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

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 ...

Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after ...

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

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