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

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

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

Moderna had designs on releasing a combined influenza and covid-19 vaccine after some promising trials, but this week the ...

Historically, almost everyone has been eligible for Covid vaccines; the C.D.C. recommended the most recent vaccine for all ...

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy ...

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 filed for FDA approval of its mRNA-1083 combination shot last year. The submission put the biotech on track to win ...

After the FDA asked for more clinical data in May 2025, Moderna has decided to resubmit the BLA later this year.

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

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...