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

A Department of Health and Human Services spokesperson called the move "a radical departure from past practices." ...

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 ...

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

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

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

The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...

The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...

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

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

The potential change outlined in a statement would require all new vaccines to undergo placebo testing, sparking concerns ...