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

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

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

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 ...

Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might ...

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

Ghana will pilot a Pregnancy Registry in early 2026 to monitor vaccine safety among pregnant women and their babies.

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