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 head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...

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

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

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

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 ...

A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say ...

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

01. Confusion over the Food and Drug Administration’s delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend when the agency’s commissioner, Marty Makary ...

Under emergency use, vaccines can be removed even after a health emergency is considered to be over. Full approval from the ...