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 ...

Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine.

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 ...

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 ...

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

Confusion over the Food and Drug Administration’s delay in granting full approval to Novavax’s Covid-19 vaccine deepened ... took to social media to defend the FDA’s controversial handling ...