Truvada (Emtricitabine/tenofovir disoproxil fumarate tablets)
November 1st 2012New combination: FDA approved the combination tablet of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (Truvada, Gilead Sciences) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV-1 in adults at high-risk in combination with safer sex practices.
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FDA Actions in Brief October 2012
November 1st 2012Recent FDA Approvals (through October 2012) related to (Perampanel, Eisai, Ocriplasmin, ThromboGenics, Paclitaxel protein-bound particles for injectable suspension, Celgene, tocilizumab, Genentech, Cysteamine ophthalmic solution, Sigma-Tau Pharmaceuticals, APTIMA HPV 16 18/45 Genotype Assay, Hologic, Adalimumab, Abbott, Regorafenib, Bayer HealthCare, Onyx)
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Disease-modifying therapies for multiple sclerosis: Focus on future direction
November 1st 2012Multiple sclerosis (MS) is a neurologic disorder of chronic inflammation and demyelination of the central nervous system. Several additional agents, including oral products, are now under investigation for the future treatment of MS.
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Discontinuation of warfarin therapy higher than generally anticipated
October 29th 2012Among older adults with atrial fibrillation (AF), persistence with warfarin therapy is generally lower than what has been reported in clinical trials, according study online in Archives of Internal Medicine.
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FDA approves Synribo for chronic myelogenous leukemia
October 26th 2012FDA has approved omacetaxine mepesuccinate (Synribo, Teva) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease. An estimated 5,430 people will be diagnosed with CML in 2012, according to the National Institutes of Health. Synribo is intended to be used in patients whose cancer progressed after treatment with at least 2 drugs from a class called tyrosine kinase inhibitors (TKIs), also used to treat CML.
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