Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...

Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the ...

The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' drug for a type of hereditary swelling ...

The FDA plans to "unleash AI" on new drug evaluations in order to "radically increase efficiency in the review process." ...

Stringent action, including licence cancellations, fines and legal proceedings, will be initiated against establishments ...

The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include people 18 to ...

The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on ...

FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.

Merck has received approval from the Food and Drug Administration to expand use of its blockbuster drug, Keytruda, to treat ...

A new article in the Journal of the American Medical Association said the FDA will implement AI into multiple processes.