The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

The U.S. Food and Drug Administration is now requiring two common COVID-19 vaccines to update their warning labels to include information on two rare heart side effects: myocarditis and pericarditis.

After federal health officials made abrupt changes to US Covid-19 vaccine recommendations for pregnant women last month, there’s new confusion and uncertainty about who can get the shots — and ...

This is the same limited use the FDA set in licensing the Novavax COVID-19 vaccine last month. This fall, Moderna anticipates offering both Spikevax and mNexspike as COVID-19 vaccines.

The Food and Drug Administration expanded the approval of Moderna’s RSV vaccine on Thursday, extending the license to include adults aged 18 to 59 who are at high risk of severe illness if they ...

The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity in some patients, citing a recent study and new data.

The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include people 18 to 59 years old who are at increased risk for severe illness from ...