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

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

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning ...

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

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

The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis and pericarditis.

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 ...

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 ...

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

Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after ...