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FDA Advisory Committee
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FDA's First Weight-Loss Device TP for Obese Adults to Dieting and Having Bariatric Surgery
Jan 19, 2015The EnterMedics Maestro Rechargeable System weight loss treatment device is effective although scientists are unclear why. The FDA has approved the first weight-loss device since 2007, giving obese adults an alternative to dieting and ...
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Naproxen Is Safer for The Heart Than Other Popular Anti-inflammatory Drugs
Feb 25, 2014TUESDAY Feb. 10, 2014, 2014 -- The science isn't convincing enough to say that naproxen -- the key pain reliever in Aleve -- is safer for the heart than other popular anti-inflammatory drugs such as ibuprofen (Advil and Motrin), U.S. health ...
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The FDA Has Rejected The New Multiple Sclerosis Drug Lemtrada
Jan 6, 2014The FDA has rejected the new multiple sclerosis drug Lemtrada, saying the drugmaker didn't show the drug's benefits outweigh some serious risks. The agency asked the maker, Genzyme, to test the drug in more clinical trials. The drug was ...
Tags: FDA, Lemtrada, Genzyme, relapsing-remitting MS, rejection
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FDA Allergenic Committee Will Meet to Discuss Bla for Ragweed Sublingual AIT Tablet
Dec 30, 2013Denmark-based pharmaceutical company ALK-Abello has announced that the FDA Allergenic Products Advisory Committee of the US Food and Drug Administration (FDA) will meet on 28 January 2014 to discuss the biologic license application (BLA) ...
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EMDAC of The US FDA Voted in Favor of Approval of Vimizim for The Treatment
Nov 26, 2013US-based BioMarin Pharmaceutical has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted in favor of approval of Vimizim for the treatment of Morquio A ...
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Amarin Announced Committee Has Voted 9 to 2 Against Approval of Vascepa Capsules for Use
Oct 18, 2013Amarin, a biopharmaceutical company, has announced the outcome of the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee for the use of Vascepa (icosapent ethyl) capsules in the treatment of high ...
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FDA Laid out The Kind of Scientific Studies Generic Companies Need to Submit
Sep 12, 2013One of the world's top-selling drugs—GlaxoSmithKline PLC's $8-billion-a-year asthma treatment Advair—became more vulnerable to generic competition after the U.S. Food and Drug Administration issued guidance on the regulatory ...
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FDA Cardiovascular and Advisory Committee Has Recommended Approval of Oral sGC Stimulator
Aug 9, 2013The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has recommended approval of Bayer’s oral soluble guanylate cyclase (sGC) stimulator, riociguat, in two forms of pulmonary ...
Tags: FDA Advisory Committee
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EnteroMedics Is Planning to Submit PMA for VBLOC Therapy in Second Quarter of 2013
May 22, 2013EnteroMedics is planning to submit the pre-PMA (Premarket Approval) application for its Maestro Rechargeable System's VBLOC vagal blocking therapy, based on the ReCharge Pivotal Trial, in the second quarter of 2013. The decision follows ...
Tags: Enteromedics, VBLOC Therapy
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Clinical Study Data of Mitraclip System Has Been Reported by Abbott
Mar 13, 2013Abbott has presented clinical study data from a Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II ) High Surgical Risk cohort of its MitraClip System for the treatment of mitral regurgitation (MR). The CE-marked catheter-based ...
Tags: clinical study, MitraClip System, medical
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FDA Recommended Approval of Gilead's Quad to Treat HIV-1 Infection
Dec 7, 2012The Antiviral Drugs Advisory Committee of the FDA has recommended the approval of Gilead's Quad to treat HIV-1 infection in treatment-naive adults. The Quad is a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine ...
Tags: gilead's quad, HIV-1, quad NDA
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FDA Advisory Committee Suggests Raxibacumab for Inhalational Anthrax
Nov 27, 2012The Anti-Infective Drugs Advisory Committee to the US Food and Drug Administration (FDA) has supported the clinical benefit of GlaxoSmithKline's raxibacumab to treat inhalational anthrax. In addition, the committee also favoured the ...
Tags: The Anti-Infective Drugs, raxibacumab anti-toxin development programme