The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 ...

Officials in sixteen states and the District of Columbia sued in response, leading to Tuesday’s order from U.S. District ...

The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but ...

A combination shot for flu and COVID-19 using messenger RNA generated antibodies in a study, but U.S. government regulators ...

Moderna’s study, involving 8,000 adults 50 and older, showed the new combo shot generated an immune response against COVID and most strains of flu compared to existing stand-alone shots.

The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.

The unusual move at FDA comes shortly after the agency's longtime vaccine chief was forced out over disagreements with Makary ...

Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking ...

The FDA recently asked Novavax to develop a plan for collecting additional clinical data from those who have gotten the shot, the company said in a statement. It said it is “engaging with the ...

WASHINGTON (AP) — Novavax’s closely watched COVID-19 vaccine is on track for full approval after additional discussions with the Food and Drug Administration, the company said Wednesday.