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

The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...

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

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

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

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

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

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 ...

Have you ever wondered about what became of COVID vaccine companies after the pandemic settled down? Find out in this article ...

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

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