FDA approves Cometriq to treat rare type of thyroid cancer

The US Food and Drug Administration today approved Cometriq ( cabozantinib ) to treat medullary thyroid cancer that has spread to other parts of the body (metastasized).

Ranbaxy Issues Voluntary Nationwide Recall of Atorvastatin Calcium

On November 9, 2012, Ranbaxy Inc. initiated a voluntary recall of 41 affected lots of atorvastatin calcium tablets (10 mg, 20 mg and 40 mg) which is a solid oral dosage form, to the retail level.

FDA approves first seasonal influenza vaccine manufactured using cell culture technology

The US Food and Drug Administration announced today the approval of Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs.

FDA Approves Pump for Heart Failure Patients Awaiting Heart Transplant

The US Food and Drug Administration today approved the HeartWare Ventricular Assist System, a left ventricular assist device (LVAD), to support heart function and blood flow in patients with end-stage heart failure who are awaiting a heart transplant.

FDA Approves First Drug-Eluting Stent to Treat Peripheral Arterial Disease

The U.S. Food and Drug Administration approved the Zilver PTX Drug-Eluting Peripheral Stent ( Zilver PTX Stent), the first drug-eluting stent indicated to re-open a particular artery in the thigh ( femoropopliteal artery) when narrowed or blocked as a result of peripheral artery disease (PAD).

FDA Approves Prostate Cancer Imaging Agent

The US Food and Drug Administration approved the production and use of Choline C 11 Injection, a positron emission tomography (PET) imaging agent used to help detect recurrent prostate cancer.

FDA Approves New Multiple Sclerosis Drug

The US Food and Drug Administration approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).

FDA Takes Charge Against Illegal Internet Pharmacies

The US Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers.

FDA Expands Use of Sapien Heart Valve

The US Food and Drug Administration today expanded the approved indication for the Sapien Transcatheter Heart Valve (THV) to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.

FDA Approves New Seizure Drug

The US Food and Drug Administration approved Fycompa (perampanel) tablets to treat partial onset seizures in patients with epilepsy who are ages 12 years and older.