The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

The leader of the U.S. FDA's division that oversees vaccines, Vinay Prasad, overruled the recommendations of his agency's ...

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

Records show that a top U.S. regulator rejected the recommendations of agency experts and limited the use of Covid vaccines.

This article has been updated. The Food and Drug Administration gave Covid vaccine manufacturers instructions on what next fall’s Covid vaccines should target on Thursday, signaling it would ...

The Food and Drug Administration (FDA) has changed its guidance regarding who should receive a COVID-19 booster. Earlier this week, the agency announced that starting this fall, the vaccines will ...

The FDA has approved a breakthrough preventative treatment for HIV that could change the course of the AIDS epidemic. But ...

One of the major complaints levied against FDA by the current administration is that the approval process is too complicated, takes too long, and needs to be modernized. The new leadership pledged to ...

The FDA has approved expanded use of Sanofi Pasteur’s MenQuadfi, a meningococcal conjugate vaccine for children aged 2 to 10. MenQuadfi is now the first quadrivalent conjugate vaccine licensed ...

The FDA expanded the approval of Moderna’s RSV vaccine, extending the license to include more adults and giving the company a welcome win.

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.

The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.