Posts Tagged ‘FDA panel’

March 21st, 2013

FDA Panel Gives Tepid Endorsement to Abbott’s MitraClip

The FDA’s Circulatory System Devices advisory panel gave a tepid endorsement to Abbott Laboratories’ MitraClip device on Wednesday. The panel met to evaluate use of the novel device in patients with significant symptomatic mitral regurgitation (MR) who  have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing […]

October 16th, 2012

FDA Review Raises Safety Concerns About Mipomersen

An FDA review raises a number of potentially significant safety concerns about the cholesterol-lowering drug mipomersen. The review appears ahead of a Thursday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to evaluate Genzyme’s new drug application (NDA) for use of the drug as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce […]

May 23rd, 2012

FDA Advisory Committee Recommends Against ACS Indication for Rivaroxaban

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted today against adding an indication for acute coronary syndromes (ACS) to the label of the anticoagulant rivaroxaban (Xarelto). The vote was 6 to 4 against approval, with 1 abstention. The advisory panel spent most of the day trying to reconcile diametrically opposed views of the pivotal ATLAS ACS 2-TIMI […]