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

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

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

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

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

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

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

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

Five years after the worldwide hyperfocus on COVID-19 began, some are concerned about the next pandemic — whether it could be ...

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

CVS Health's insurance division, based in Hartford, will pull out of Affordable Care Act exchanges as of next year as planned ...

This is the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and ...