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

The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...

WASHINGTON - The U.S. Department of Health and Human Services announced this week that it will add a step to the testing of ...

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

A major change in the way HHS plans to evaluate vaccine safety is raising fears that approvals will become unnecessarily ...

The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine is sowing uncertainty about other ...

Per the Post, which first reported the story, “‘All new vaccines will undergo safety testing in placebo-controlled trials ...

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

The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and ...

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

Novavax’s COVID-19 vaccine could soon receive full approval from the U.S. Food and Drug Administration (FDA), the company said Wednesday. The update sent Nova ...

Several current and former FDA employees who spoke to Inside Medicine on the condition of anonymity have come to see the ...