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 Thursday that it aims to accomplish within four years a scientific feat ...

The agency suggested that clinical trials in humans may be required for updated Covid shots, raising questions about whether ...

In a shift away from next-generation Covid-19 vaccines, the Trump administration is investing $500 million in a vaccine ...

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 it will require that all new vaccines be tested in placebo-controlled ...

Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking ...

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 ...

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

Novavax’s COVID-19 vaccine could soon receive full approval from the United States Food and Drug Administration.

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.