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 ...

“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." ...

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

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

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

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

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

On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its ...

The layoffs had decimated the workforce that processes Freedom of Information Act requests across FDA centers.

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