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FDA Advisory
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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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Afrezza Hopes That Its Inhalable Insulin Product Will Be a Gamechanger for Diabetics
Apr 8, 2014Afrezza hopes that its inhalable insulin product will be a gamechanger for diabetics. (Image courtesy Afrezza). Insulin injections may soon be a thing of the past if Mannkind Corp.'s inhalable insulin product, Afrezza, is approved by ...
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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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Boston Scientific's Watchman Left Atrial Appendage Closure Device Is Voted by FDA Panel
Dec 13, 2013The US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably by a majority that the benefits of the Boston Scientific's WATCHMAN left atrial appendage closure device ...
Tags: FDA, Boston Scientific, WATCHMAN, left atrial appendage closure device
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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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Cochlear Announced That FDA Voted Favorably on Cochlear's Nucleus Hybrid L24 Implant Syste
Nov 14, 2013US-based Cochlear has announced that an advisory committee to the US Food and Drug Administration (FDA) voted favorably on the Cochlear Nucleus Hybrid L24 implant system. This is a first of its kind system designed for the treatment of ...
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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 Has Recommended The Expanded Indication of Medtronic's CRT-P and CRT-D
Oct 10, 2013The US Food and Drug Administration (FDA) advisory panel has recommended the expanded indication of Medtronic’s cardiac resynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D) for the treatment of patients who ...
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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