The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

FDA approval of the COVID-19 vaccines, then, could spur more people to get vaccinated, potentially driving the U.S. ever closer to its herd immunity threshold: when as much as 80 percent of the ...

The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity in some patients, citing a recent study and new data.