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 US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...

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

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

A Department of Health and Human Services spokesperson called the move "a radical departure from past practices." ...

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

The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...

The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...

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

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

Kennedy and FDA Commissioner Marty Makary’s approach to assessing vaccines could put Covid boosters out of reach.