Senior Biden Food and Drug Administration (FDA) officials spent weeks casting doubt on reports of cardiac risks associated ...

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

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

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

Shares of prominent COVID-19 vaccine-makers Moderna MRNA, Pfizer PFE and BioNTech BNTX rose yesterday after the FDA issued new guidance for COVID-19 vaccine boosters. FDA’s New Requirements for ...

Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating ...