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 ...

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

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

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

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

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

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