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

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

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

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

KalVista Pharmaceuticals faces delays from the U.S. Food and Drug Administration as it looks to get approval for its new drug application for sebetralstat, a treatment for hereditary angioedema.

The Food and Drug Administration expanded the approval of Moderna’s RSV vaccine on Thursday, extending the license to include ...

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 ...

And there is no F.D.A. requirement for a fatty acid called docosahexaenoic acid, or DHA, which is important for brain ...

The Food and Drug Administration said approved UroGen Pharma’s (URGN) Zusduri for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The agency pointed out ...