The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration voted to recommend approval for Mallinckrodt’s investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).
AstraZeneca’s blockbuster drug Farxiga won U.S. approval as a treatment to reduce the chances of hospitalization for heart failure in adults with type 2 diabetes and other cardiovascular risks.
The U.S. Food and Drug Administration granted fast track status for the development of AstraZeneca’s diabetes drug Farxiga to prevent heart and kidney failure in patients with chronic kidney disease.
Janssen’s Invokana became the only medicine in nearly 20 years and the first diabetes medicine ever to demonstrate a reduction in progression to end-stage renal failure in T2D patients with CKD.
U.S. health regulators approved Amicus Therapeutics’ Galafold as the first oral therapy to treat Fabry disease, a rare and sometimes fatal condition.
Retrophin Inc. said its drug to treat a rare kidney disorder was found effective in a mid-stage study.