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 ...

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

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

The unusual move at FDA comes shortly after the agency's longtime vaccine chief was forced out over disagreements with Makary ...

There's new uncertainty about updated COVID-19 shots this fall after the Trump administration's handling of a shot from ...

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

“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.