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 ...

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

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 ...

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 ...

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

Researchers aim to develop a universal vaccine platform that could protect against both COVID-19 and influenza without annual ...

The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.

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