The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a ...

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 ...

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 ...

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

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

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

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

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

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

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