Regeneron Pharmaceuticals (NASDAQ:REGN) said on Thursday that the U.S. FDA will be reviewing the supplemental biologics ...

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

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

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

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

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 ...

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

Princeton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has updated the U.S.

Vanda is criticizing the FDA’s restrictions on information companies can provide regarding off-label use of approved ...

Bristol Myers Squibb BMY announced that it has obtained FDA approval for the label expansion of Opdivo (nivolumab) plus Yervoy (ipilimumab). The regulatory body approved Opdivo plus Yervoy as a ...

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 ...