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 Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...

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 ...

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

Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine.

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

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

The U.S. government is putting down $500 million toward the development of a “universal” vaccine—a shot designed to protect ...

On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its ...

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