The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at ...

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit ...

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...

The FDA will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...

For groups younger than 65 or without specific chronic conditions, postmarketing trials will be needed to open access.

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

The U.S. Food and Drug Administration approved Novavax's COVIDd-19 vaccine with age restrictions after a six-week delay.

Under a new policy announced Tuesday by the Trump administration, only people age 65 and older and children or young adults ...

President Donald Trump's tax cut and spending bill faces a critical stress test on Wednesday as Republicans in the U.S. House ...

The Food and Drug Administration is telling Pfizer and Moderna to expand the warning labels on their COVID-19 vaccines about ...

The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the ...