There were over 1.5 million "missing Americans" in 2022 and 2023, deaths that would have been averted if US mortality rates matched those of peer countries.

In a major and controversial policy shift, the FDA announced in a New England Journal of Medicine article that updated ...

The notice came shortly after an advisory panel meeting at which members debated the pros and cons of asking manufacturers to ...

U.S. Food and Drug Administration advisers unanimously recommended on Thursday that COVID-19 vaccines for the 2025-26 period ...

On May 22, an FDA advisory committee unanimously recommended COVID-19 vaccine manufacturers target the JN.1 variant in their formulations.  The Vaccines and Related Biological Products Advisory ...

The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

Despite the fact that vaccines against COVID have already undergone strict safety reviews and that people continue to die ...

The vaccine is expected to remain available for anyone who is at least 65 or who has a medical condition, leaving many Americans ineligible. Here's what we know.

The FDA is implementing stricter guidance for the approval of COVID-19 vaccines, according to a paper published in The New England Journal of Medicine.

The US Food and Drug Administration has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines.

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

At the outset of the meeting, the FDA's new top vaccine regulator, Vinay Prasad, said he and FDA leaders wanted to "give people a little more time to digest the policy." He said that the FDA is still ...