The framework the new FDA leaders laid out on Tuesday raised small and big questions about the regulatory process, vaccine ...

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

CAMBRIDGE, MA / ACCESS Newswire / May 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an ...

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 ...

Government advisers debate updating COVID-19 vaccines for next season amid confusion over new U.S. policy on booster shots.

The US FDA may limit Covid-19 boosters to high-risk groups only, citing lack of efficacy in healthy individuals. Meanwhile, ...

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.

Some members of the Vaccines and Related Biologics Products Advisory Committee worried that a strain change would require new ...

Preliminary data from researchers in China suggest the NB.1.8.1 variant is not better at evading the immune system compared ...

The agency told vaccine makers that COVID-19 vaccines used in the United States starting in fall 2025 should be based on JN.1 ...