FDA to assess safety of Pradaxa for nonvalvular AF

January 5, 2014
The FDA has announced plans to conduct a safety assessment of dabigatran, as compared with warfarin, for the treatment of patients with nonvalvular…
FDA approvals

FDA approves Orenitram for treatment of PAH

December 26, 2013
United Therapeutics Corp. announced that the FDA approved an extended-release version of treprostinil for treatment of pulmonary arterial…

FDA approves Kcentra for warfarin reversal in emergency surgery recipients

December 17, 2013
CSL Behring announced that the FDA has approved Kcentra for the urgent reversal of acquired coagulation factor deficiency due to warfarin therapy…
FDA advisory panel decisionsPerspective

FDA advisory panel recommends approval for dapagliflozin

December 13, 2013
This week, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10-4 in favor of the updated cardiovascular risk profile of the…
FDA advisory panel decisionsPerspective

FDA panel voted in favor of Watchman device for stroke prevention

December 11, 2013
The FDA’s Circulatory System Devices Panel today voted 13-1 that the benefits of a left atrial appendage closure technology for the prevention…

FDA issues safety communication for HeartStart defibrillators

December 4, 2013
The FDA has issued a safety communication indicating that certain HeartStart automated external defibrillators may not function properly in a cardiac…

FDA designates Factor Xa inhibitor antidote breakthrough therapy

November 25, 2013
Portola Pharmaceuticals has announced that the FDA designated its investigational Factor Xa inhibitor, andexanet alfa, a breakthrough therapy…
FDA approvals

FDA approves next-generation EES

November 25, 2013
Boston Scientific has announced that its Promus Premier everolimus-eluting platinum chromium stent system has received FDA approval for the treatment…

FDA issues warning about risks with cardiac nuclear stress test drugs

November 20, 2013
The FDA has issued a safety announcement warning health care professionals of rare but serious risk for MI and death with the use of the cardiac…