Blooming Import Inc. recalled 74 cases of Golden Crop Candy sold in eight states due to undeclared dyes, including the ...

Marking the first approval in over a decade for this challenging condition, the FDA has approved dupilumab (Dupixent) to treat chronic spontaneous urticaria in patients 12 years and older whose hives ...

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

Color additives have faced increased scrutiny since the FDA banned Red Dye No. 3, citing concerns over its links to cancer.

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 ...

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, ...