After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...

Michael Moye, President and General Manager of Idorsia US, commented: “The fact that the FDA has expedited the approval of the updated TRYVIO label to remove the REMS requirements is ...

Michael Moye, President and General Manager of Idorsia US, commented: “The fact that the FDA has expedited the approval of the updated TRYVIO label to remove the REMS requirements is, I believe, a ...

A three-judge panel wrestled Thursday with Novartis AG’s challenge against the FDA over its approval of a generic version of ...

Regeneron (REGN) announces FDA review of sBLA for Eylea HD to treat macular edema and expand dosing. Read more here.

Drugmaker Eli Lilly (NYSE: LLY) hasn't been exempt from the recent market pullback, but its stock shot higher following the ...

Ellen Behrend, VMD, PhD, MS, DACVIM (SAIM) explains the differences between bexagliflozin and velagliflozin, and how to determine if a patient is a good candidate ...

From Crohn disease to uncomplicated urinary tract infections and beyond, the FDA issued several high-impact drug approvals last month.

Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval for Uplizna, now approved as a treatment for immunoglobulin G4-related ...