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 ...

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

The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.

The U.S. Health and Human Services Department says it will require placebo testing of "all new vaccines," raising questions ...

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

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

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

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

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