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FDA approves first artificial aortic heart valve placed without open-heart surgery

By medser on  From medicinezine.com
FDA approves first artificial aortic heart valve placed without open-heart surgery The U.S. Food and Drug Administration today approved the first artificial heart valve that can replace an aortic heart valve damaged by senile aortic valve stenosis without open-heart surgery. Senile aortic valve stenosis is a progressive, age-related disease caused by calcium deposits on the aortic valve that cause the valve to narrow. As the heart works harder to pump enough blood through the smaller valve...Read Full Story

FDA approves Merck's new diabetes therapy combo

 From reuters.com
( Reuters ) - U.S. health regulators approved a new combination therapy for type 2 diabetes from Merck & Co, the first to combine a diabetes drug with cholesterol-lowering medicine in one tablet. Merck's new drug Juvisync combines the drugmaker's diabetes medicine Januvia , which helps lower high blood sugar levels, with simvastatin, a commonly prescribed statin that helps lower cholesterol alongside diet and exercise. About 20 million Americans have type 2 diabetes, and many of them also...Read Full Story

Stop-Smoking Drug Chantix Ups Risk of Heart Problems: Study

By kevinabramson on  From myoptumhealth.com
Risks outweigh benefits, even for people without pre-existing heart disease, researchers say Share What is this? Twitter Digg Facebook More... EMAIL PRINT RSS   MONDAY, July 4 (HealthDay News) -- The quit-smoking drug Chantix may increase the risk of heart attacks and strokes by as much as 72 percent in smokers who take it, even those without heart disease, researchers say. The new study comes just over a week after the U.S...Read Full Story

FDA approves Discovery Labs Afectair

By jackingram on  From anesthesiarespiratorydevices.medicaldevices-business-review.com
The US Food and Drug Administration (FDA) has approved Discovery Laboratories' proprietary patient interface technology, Afectair.Read Full Story

Pfizer anti-smoking drug has heart risks: US

 From afp.com
US regulators said Thursday that the label on Pfizer's anti-smoking drug Chantix must be changed to warn of a slightly higher risk of heart problems in patients who already have cardiovascular disease. The drug, also known as varenicline, was shown in a clinical trial of 700 smokers to be associated with an elevated risk of heart attack, angina, and clogged arteries in some patients when compared to a placebo. "The prescribing information for this drug product will be strengthened to inform...Read Full Story
“Prostaglandin analogs are often used as a first line of treatment to lower intraocular pressure in patients with open-angle glaucoma. The approval of ZIOPTAN will provide a new, effective option to lower IOP,” said George L. Spaeth, M.D., Wills Eye ...  
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On Monday, the US Food and Drug Administration approved a new type of drug to treat adult patients with advanced basal-cell carcinoma, the most common type of skin cancer. The drug's generic name is vismodegib and was developed by the US part of Roche Holding AG. It will be sold in the US by Roche's South San Francisco-based Genentech under the brand name Erivedge. Basal cell carcinoma is a slow growing, painless cancer that starts in the...  
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Sanofi announced today that the U.S. Food and Drug Administration (FDA) has approved Sklice® (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. Effective and well-tolerated, Sklice Lotion ...  
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... and Drug Administration has approved the stimulant medication lisdexamfetamine dimesylate (Vyvanse, Shire) as maintenance therapy for adults with attention deficit hyperactivity disorder (ADHD). According to a press release issued by the ...  
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NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved INLYTA (axitinib), a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. The approval is based on data from the Phase 3 AXIS trial, which demonstrated that INLYTA significantly extended progression free...  
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RIDGEFIELD, Conn., and INDIANAPOLIS, Jan. 30, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has approved Jentadueto™ (linagliptin/metformin hydrochloride) tablets, a...  
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WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved JANUMET® XR (sitagliptin and metformin hydrochloride (HCl) extended-release) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of JANUVIA® (sitagliptin), with extended-release metformin. JANUMET XR provides a...  
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