Posts Tagged ‘advisory panel’

March 27th, 2014

FDA Advisory Panel Recommends Against Approval of Novartis Heart Failure Drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously (11-0) against approval of the biologics license application (BLA) for serelaxin (proposed trade name, Reasanz). The novel drug from Novartis was intended to be used in patients with acute heart failure (HF). The once highly promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was also turned down for approval […]