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

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.

Preliminary data from researchers in China suggest the NB.1.8.1 variant is not better at evading the immune system compared ...

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 ...

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

Advisers to the U.S. Food and Drug Administration on Thursday unanimously voted in favor of recommending that COVID-19 ...

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

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

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