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 ...

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 travelers with cases linked to the NB.1.8.1 variant have been arriving at airports in California, Washington state, ...

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 ...

Secretary Kennedy's appointment led to fears that vaccine availability would be curtailed. Those fears are now being realized.

Infectious disease experts say mRNA vaccines have been studied for decades, they are safe and effective, and were instrumental in saving lives during the COVID pandemic.