Elsa” is the FDA’s new anthropomorphized AI tool which, the FDA hopes, will speed up clearances, licenses, and approvals ...

A recall of certain cases of Floria Dried Apricots is underway due to their packaging not disclosing the fruit contains ...

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.

Vitamin gummies sold a BJ’s and ALDI stores nationwide are being recalled due to potential presence of peanuts, according to ...

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

The drug is already approved for KMT2A-rearranged AML, and Syndax is hoping for approval in NPM1-mutated disease by the end of the year.

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

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

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

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

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