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 ...

Moderna Inc. shares declined after the company’s first-quarter vaccine sales missed estimates and it disclosed a delay in the ...

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.

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

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

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

The health department did not provide details on how the proposed changes will be enforced or to which vaccine trials they ...

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

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