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 ...

If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...

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

“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.

The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...

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

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

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 ...

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

Researchers aim to develop a universal vaccine platform that could protect against both COVID-19 and influenza without annual ...