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

The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...

The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a ...

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 ...

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

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

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

FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.

Kennedy and FDA Commissioner Marty Makary’s approach to assessing vaccines could put Covid boosters out of reach.

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

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...