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

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

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

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

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

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

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.

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 ...

The FDA may be making changes to how it handles COVID-19 booster shots. The agency’s top official says they’re taking a closer look at whether to approve boosters for this winter.