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

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

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

The US Food and Drug Administration will require all new vaccines go through placebo-controlled studies before they are ...

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

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

The Department of Health and Human Services said it is redirecting funding from what it calls a wasteful Biden-era project on ...

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

“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 ...

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

FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.