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Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide
Written by IV Post   
Thursday, 07 May 2009
Washington, DC - The U.S. Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels.
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FDA Approves Pancreatic Enzyme Replacement Product Creon
Written by FDA   
Thursday, 07 May 2009
Washington, DC - The U.S. Food and Drug Administration announced today that it has approved Creon (pancrelipase), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis and others with exocrine pancreatic insufficiency (EPI) digest and absorb nutrients from foods.
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FDA Approves Fanapt to Treat Schizophrenia
Written by IV Post   
Thursday, 07 May 2009
Washington, DC - The U.S. Food and Drug Administration has approved Fanapt tablets (iloperidone) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder.
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FDA Approves New Influenza Vaccine Production Facility
Written by IV Post   
Thursday, 07 May 2009
Swiftwater, Pennsylvania - The U.S. Food and Drug Administration (FDA) today announced that it has approved a new manufacturing facility used to produce influenza virus vaccines.  The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.

 

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Non-Alcoholic Fatty Liver Disease Shown to Run in Families
Written by UC San Diego   
Monday, 04 May 2009

San Diego, California - Family members of children diagnosed with non-alcoholic fatty liver disease (NAFLD) should be considered at high risk for the disease and tested for it as part of a routine medical examination, even if they don’t show symptoms, according to a recent study by researchers at the University of California, San Diego School of Medicine. 

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FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products
Written by IV Post   
Monday, 04 May 2009

Washington, DC - The U.S. Food and Drug Administration and the Federal Trade Commission are alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus.  The agencies are also advising operators of offending web sites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.

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FDA Warns Consumers to Stop Using Hydroxycut Products
Written by IV Post   
Monday, 04 May 2009

Washington, DC - The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

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