The FDA is forcing Pfizer and Moderna to expand warning labels about the risks of two forms of heart damage, myocarditis and ...

Key Takeaways Federal regulators have issued a warning about rare heart inflammation in young males after mRNA COVID ...

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

The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from ...

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.

Moderna's voluntary withdrawal of the filing stems from the FDA's request for vaccine efficacy data from a phase III study on ...

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

Advisers to the Food and Drug Administration met Thursday to help decide which variant of the virus that causes COVID should ...

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

FDA COVID vaccine update is stirring major public attention as a new policy limits fall COVID-19 booster shots to seniors and ...

The FDA may limit annual COVID-19 boosters to high-risk groups unless clinical trials prove benefits for healthy adults under 65. Pfizer is reviewing the plan, while officials call for more evidence ...

The FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to receive booster shots. FDA officials are asking for more data around the ...