The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna ...

The Food and Drug Administration (FDA) has introduced new guidelines for COVID-19 vaccines, focusing on those at highest risk for severe complications. The updated strategy will maintain the ...

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively limiting them to ...

Top officials for the Food and Drug Administration laid out new requirements ... to COVID-19 vaccines, similar to the annual flu shot. Just like with flu vaccines, until now the FDA has approved ...

The U.S. Food and Drug Administration plans to require new ... The FDA’s vaccine advisory committee is scheduled to meet later this week to discuss which variant of the coronavirus vaccine ...

Top officials for the Food and Drug Administration laid out new requirements ... to COVID-19 vaccines, similar to the annual flu shot. Just like with flu vaccines, until now the FDA has approved ...

The Trump administration released a more stringent set of guidelines for approving Covid-19 ... approval, FDA Commissioner Dr. Marty Makary and the agency’s new vaccines chief, Dr. Vinay Prasad ...