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 ...

The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a ...

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

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

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

“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 ...

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

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

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 ...

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...