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

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

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

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

“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 ...

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

IO Biotech's first-in-class vaccine performs double duty, killing cancer cells and enhancing the tumor microenvironment. A ...

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 ...

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

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