Melanoma Drug, Vemurafenib, Approved By US FDA
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The drug vemurafenib (Zelboraf) for metastatic melanoma in patients who test positive for the BRAF mutation, has been approved by the U.S. Food and Drug Administration. Vemurafenib, a BRAF-inhibitor, is a personalized investigational drug designed to specifically inhibit the activity of the mutant BRAF protein that is present in almost half of all melanoma cases, the most lethal and aggressive...
Top-Quality Clinical Studies For Medical Devices, FDA Seeks Feedback On Proposed Guidelines
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In order to optimize the standard of clinical studies that support the PMA (premarket approval) submissions for medical devices, the FDA has issued a draft guidance. The FDA (Food and Drug Administration) says its draft guidance aims to help manufacturers and researchers design better quality clinical studies. The Agency is also calling on experts, manufacturers, researchers, and other groups...
Multaq (dronedarone) Has Higher Death, Stroke And Heart Failure Risk For Patients With Permanent Atrial Fibrillation, FDA Warning
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Patients with permanent atrial fibrillation who take Multaq (dronedarone), an antiarrhythmic medication, have double the risk of death and double the risk of being hospitalized for heart failure or developing stroke compared to those on a placebo, the FDA announced after the evaluation of a clinical trial. The trial was halted early because of these findings.
Multaq was originally approved by...
2011-2012 Flu Vaccines Approved By FDA
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Six manufacturers have had their flu vaccines approved by the FDA (Food and Drug Administration) for the coming 2011-2012 season. The Agency explained in a communiqué that vaccination is crucial in the drive to control influenza, a contagious respiratory infection caused by influenza virus strains.
This year’s vaccine formulation is aimed at protecting against three virus strains that...
Triple Vaccine Boostrix Approved For Senior Patients By US FDA
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The FDA (US Food and Drug Administration) has approved the triple vaccine “Boostrix” – for tetanus, diphtheria and pertussis (whooping cough) – for individuals aged 65+ years. Boostrix is made by GlaxoSmithKline Biologicals. This is the first triple vaccine for older patients. Before Boostrix’s approval, available multiple vaccines only protected against tetanus...
FDA: California Seafood Handler Enters Into Consent Decree
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The U.S. Food and Drug Administration and San Diego-based Ocean Harvest Inc., an outlet for salmon, tuna, and other fresh fish intended for raw consumption, and Ocean Harvest president, Minkyu Park, recently signed a consent decree of permanent injunction. The company had been selling seafood that was handled in violation of federal food safety standards.
The consent decree restrains Ocean Harvest...
FDA Approves New J&J Combo HIV Drug For The Treatment Naive
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Well at least there is some progress in treating one of the world’s deadliest epidemics. This week the U.S. Food and Drug Administration (FDA) today approved Edurant, or rilpivirine, in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV treatments. These patients are also known as “treatment naive.”
Edurant...
Afinitor (everolimus) For Rare Pancreatic Cancer Approved By FDA
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Afinitor (everolimus), a medication for patients with PNET (progressive neuroendocrine tumors) in the pancreas whose tumor cannot be surgically removed or whose cancer has metastasized (spread), has been approved by the Food and Drug Administration (FDA).
Neuroendocrine tumors located in the pancreas are rare and grow slowly. According to the CDC, there are approximately 1,000 newly diagnosed...
Menactra, Meningococcal Vaccine For Infants From 9 Months Approved By FDA
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Menactra, a vaccine for the prevention of invasive meningococcal disease for children from 9 months of age has been approved by the FDA (Food and Drug Administration). The vaccine, which is already on the market for patients aged between 2 and 55 years, protects against Neisseria meningitides serogroups A, C, Y and W-135.
Meningococcal disease refers to infection caused by Neisseria meningitides,...
Many Dieters Eating Wrong Foods Due To Misleading Labeling
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Dieters are more drawn to such words in labels as healthy than non-dieters, which would be OK if all labels were super honest, unfortunately a considerable number are misleading and dieters often end up eating the complete opposite – unhealthy foods, according to an article published in The Journal of Consumer Research.
A fat and calorie laden milkshake that is called a fruit smoothie is...
