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

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

The Food and Drug Administration was set to release new guidance on COVID booster shots ahead of the fall season, but that's ...

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

Federal regulators are asking Novavax to complete an additional randomized clinical trial on its Covid-19 vaccine after ...

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

In recent years, the FDA decided on formulations for annual COVID shots around June, with doses rolled out in the fall alongside flu shots. However, this process is now in question based on ...

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.

Novavax's COVID-19 vaccine could soon receive full approval from the U.S. Food and Drug Administration (FDA), the company ...