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

Trump admin's new FDA update limits annual COVID shots to high-risk groups, ending routine access for healthy kids and adults ...

The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded ...

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.

The FDA is also expanding its warning that some vaccines are linked to a risk of heart inflammation in young men.

Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are ...

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

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes.

After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter ...

Large, lengthy studies will be needed for the agency to approve boosters for healthy adults and children, regulators said.