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

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

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

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 ...

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.

The U.S. Department of Health and Human services says it will require all new vaccines to be tested in placebo-controlled ...

Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...

The Department of Health and Human Services says it will require new vaccines to be tested against a placebo, which could ...