Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

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

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 ...

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

Health Secretary Robert F. Kennedy Jr. on Thursday announced plans to require all new vaccines to be tested against placebos ...

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

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

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

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

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

From STAT’s Jason Mast: Moderna said this morning in its earnings report it planned to cut costs by around $1.5 billion by ...