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

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.

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 ...

Reese Marketos played the role of government prosecutor in a False Claims Act case about alleged off-label use of an HIV drug ...

Approval of Opdivo plus Yervoy combination was based on results from the Phase III CheckMate-9DW trial, which demonstrated ...

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, I believe, a ...

Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval ...

ILUVIEN now approved for the treatment of chronic non ... ANI plans to begin marketing ILUVIEN in the U.S. under the combined label later this year Nikhil Lalwani, President and CEO of ANI stated ...

Rapid initiation Protocol: Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability.