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FDA, COVID-19 and vaccine
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This vaccine did previously have emergency approval by the FDA for use but can now be marketed in the U.S. for use, the ...
A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make ...
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.
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.
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