Treatments for COPD, psoriasis, and neuroendocrine tumors, as well as a next-generation COVID-19 vaccine are under review.

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

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

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

The Food and Drug Administration (FDA) has approved Isturisa ® (osilodrostat) for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome for whom surgery is not an option or has ...

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

FDA officials announced today that they have approved a label expansion for sarolaner, moxidectin and pyrantel chewable ...

Flea tapeworms are found in canine intestines and transmitted to dogs when fleas carrying tapeworm eggs are accidentally ...

Bristol Myers gets FDA approval for Opdivo monotherapy and Opdivo plus Yervoy combination for colorectal cancer in the ...

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 ...