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 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 ...

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 US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...

Moderna is deprioritizing its flu/COVID combination vaccine in younger adults amid a push to cut about $1.5 billion from its ...

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 ...