GSK Update On FDA Review Of Promacta R Eltrombopag

GlaxoSmithKline (NYSE: GSK) announced that the United States Food and Drug Administration has extended the priority review period for PROMACTA(R) (eltrombopag) for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura, as they require more time to review the application.

FDA Approves GlaxoSmithKline's AVODART R In Combination With Tamsulosin For The Treatment Of Symptomatic Enlarged Prostate

GlaxoSmithKline (NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has approved AVODART (dutasteride) in combination with tamsulosin for the treatment of symptomatic enlarged prostate, a disease that affects half of all men over 50 years old.

FDA Warns Individuals And Firms To Stop Selling Fake Cancer 'Cures'

Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

FDA Advisory Committee Unanimously Recommends Approval Of Ustekinumab For Treatment Of Moderate To Severe Plaque Psoriasis

Centocor, Inc. announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) has unanimously recommended the approval of ustekinumab, a new subcutaneous, investigational biologic therapy for the treatment of adult patients with moderate to severe plaque psoriasis.

FDA Approves Cymbalta reg; For The Management Of Fibromyalgia

The U.S. Food and Drug Administration (FDA) has approved Cymbalta (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company (NYSE: LLY) announced. Cymbalta is the first serotonin- norepinephrine reuptake inhibitor with proven efficacy for reducing pain in patients with fibromyalgia.

Deaths May Have Been Caused By Abortion Drug's Off-Label Use

Preliminary U-M studies indicate that oral use of RU-486's companion drug misoprostol is safe, but vaginal use may undermine body's immune responsesThe off-label use of a drug given with RU-486 to terminate a pregnancy may be responsible for a handful of rare, fatal infections seen in women taking the drugs since 2000, a study by University of Michigan scientists suggests.

Nationwide Data Indicate A Very High Degree Of Accuracy For OraQuick ADVANCE Rapid HIV-1 2 Antibody Test With Oral Fluid

OraSure Technologies, Inc. (NASDAQ:OSUR) announced that aggregate nationwide performance data for 2007 and the first five months of 2008 indicate that its widely used rapid HIV-1/2 antibody screening test, OraQuick ADVANCE, has a very high degree of accuracy with oral fluid - at rates that are within the U.

Cook Medical Enters Coronary Stent Market In Europe With New CoCr Stent

Global Therapeutics, the cardiology unit of Cook Medical, has received CE Mark approval for a new cobalt chromium bare metal coronary stent that company executives believe will fill a demand for non-drug eluting coronary stents among interventional cardiologists, the company announced today.

Synapse Biomedical Receives FDA Approval Of NeuRx Diaphragm Pacing System DPS TM For Spinal Cord Injury Breathing Applications

Synapse Biomedical Inc. (http://www.synapsebiomedical.com) announced it has received approval from the U.S. Food and Drug Administration (FDA) for its NeuRx DPS(TM) for ventilator-dependent Spinal Cord Injury (SCI) patients who lack voluntary control of their diaphragms.

European Medicines Agency Recommends Measures To Manage Contamination Ofheparin-Containing Medicines

The European Medicines Agency has reviewed the risks associated with the use of heparin medicinal products contaminated with oversulphated chondroitin sulphate (OSCS). Heparins are used to prevent and treat blood clots. They are used widely in patients who could have, or have had a heart attack, in patients who have undergone major surgery, or patients on dialysis.