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

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 ...

The US Food and Drug Administration (FDA) has approved nivolumab (Opdivo, Bristol Myers Squibb) with ipilimumab (Yervoy, ...

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

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 ...

The FDA has updated the definition of "healthy" on food labels to better reflect current nutritional science. Foods must now meet criteria for beneficial nutrients and limits on added sugars, ...

The FDA approved agents in MIBC and neuroendocrine tumors and amivantamab/lazertinib continues to shine in NSCLC.