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

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 to undergo placebo-controlled trials before approval — a ...

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 ...

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 ...

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

The U.S. government is putting down $500 million toward the development of a “universal” vaccine—a shot designed to protect ...

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

From STAT’s Jason Mast: Moderna said this morning in its earnings report it planned to cut costs by around $1.5 billion by ...

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...