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 ...

“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.

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

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

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

The U.S. Health and Human Services Department says it will require placebo testing of "all new vaccines," raising questions ...

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 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” ...