FDA now requires Pfizer and Moderna COVID-19 vaccines to carry expanded warning labels about risks of myocarditis and pericarditis ...

Advisers to the FDA will debate if the virus has mutated enough since last winter to require a tweak to the formula.

Despite an explanation of the new strategy published Tuesday from FDA Commissioner Marty Makary and Vinay Prasad, who ...

The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the ...