The agency suggested that clinical trials in humans may be required for updated Covid shots, raising questions about whether ...

The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

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

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...

The U.S. government is putting down $500 million toward the development of a “universal” vaccine—a shot designed to protect ...

“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...

Moderna Inc. shares declined after the company’s first-quarter vaccine sales missed estimates and it disclosed a delay in the ...

Novavax’s COVID-19 vaccine could soon receive full approval from the United States Food and Drug Administration.

Because the coronavirus continually mutates, manufacturers follow instructions from FDA to make one change each year to their recipe — which strain to target — just like flu vaccines.

The President Donald Trump administration's request for Novavax Inc. to conduct new clinical trials for its COVID-19 vaccine ...