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 ...

The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the nation’s only traditional ...

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

The unusual move at FDA comes shortly after the agency's longtime vaccine chief was forced out over disagreements with Makary ...

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 ...

The U.S. FDA is planning to require all new vaccines to undergo placebo-controlled trials before approval. Read more here.

“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.

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

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