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

The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the nation’s only traditional ...

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

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

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

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

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 ...