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 ...

“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.

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

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 layoffs had decimated the workforce that processes Freedom of Information Act requests across FDA centers.

Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine after the agency grants full approval. The company said it had responded ...

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