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

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter ...

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

An FDA advisory committee unanimously recommended Thursday that the next COVID vaccine should be a monovalent one in the JN.1 ...

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.

After the FDA asked for more clinical data this month, Moderna has decided to resubmit the BLA later this year.

After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy ...

Moderna, Inc. (NASDAQ:MRNA) today announced that it had voluntarily withdrawn the pending Biologics License Application (BLA) ...

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 ...