The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.

The use of SGLT2 inhibitors vs sulfonylurea was associated with a reduced risk for incident gout and MACE among patients with type 2 diabetes with/at risk for gout.

Lexicon (LXRX) announced the peer-reviewed Journal of American Society of Nephrology, or JASN, has published a research paper analyzing the ...

Greatest increase in SGLT2 inhibitor use seen in subgroups with cardiovascular disease; greatest increase in GLP-1 RA for those with obesity ...

Sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors) are a relatively new group of medications originally developed ...

New research presented at the ACG Annual Meeting suggests that GLP-1RAs lower the risk of pancreatic cancer in patients with ...

GLP-1 receptor agonists do not affect cardiovascular, kidney, or safety outcomes regardless of SGLT2 inhibitor use in patients with type 2 diabetes.

Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic ...

On Halloween, Lexicon was haunted again as an FDA advisory committee voted 11-3 to reject Zynquista as an accompanying ...

Lexicon Pharmaceuticals' sotagliflozin, under review as an adjunct to insulin for type 1 diabetes and CKD, faced an FDA panel vote against approval, with mixed expert support.

While an FDA advisory committee saw signals of efficacy for Lexicon Pharmaceuticals’ sotagliflozin, the panel of external ...

Lexicon Pharmaceuticals Inc. (LXRX) announced that the U.S. Food and Drug Administration's Advisory Committee voted against the ...