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FDA accepts Kythera’s ATX-101 new drug applicationKythera Biopharmaceuticals' new drug application (NDA) for its ATX-101, a submental contouring injectable drug, has been accepted for filing by the US Food and Drug Administration (FDA). According to2014/7/14
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Iroko files new drug application for Zorvolex in LebanonUS-based Iroko Pharmaceuticals has announced the filing of a new drug application for Zorvolex, a nonsteroidal anti-inflammatory drug, with the Republic of Lebanon Ministry of Public Health (MOPH) for2014/7/14
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Letrozole boosts fertility in women with PCOS, says studyPenn State College of Medicine's nationwide study has shown that Letrozole resulted in higher birth rates in women with polycystic ovary syndrome (PCOS) than the current preferred infertility treatmen2014/7/11
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Bayer receives Canadian approval for Nexavar to treat differentiated thyroid cancerHealth Canada has approved Bayer's Nexavar (sorafenib tablets) for treatment of patients with locally advanced or metastatic, progressive, differentiated (papillary/follicular/Hurthle cell) thyroid ca2014/7/11
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Purdue’s hydrocodone bitartrate tablets granted priority review designationPurdue Pharma has been granted priority review designation by the US Food and Drug Administration (FDA) for its hydrocodone bitartrate extended-release tablets for treatment of chronic pain. The once2014/7/10
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AstraZeneca’s Forxiga receives positive advice from Scottish Medicines ConsortiumAstraZeneca announced that the Scottish Medicines Consortium (SMC) has issued positive advice for use of its Forxiga, a selective and reversible inhibitor of sodium-glucose co-transporter-2, as part o2014/7/10
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Roche receives Japanese approval for lung cancer therapyThe Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Roche's alectinib for treatment of people living with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase fusi2014/7/9
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CHMP recommends Teva’s pregnancy prevention drugThe European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the marketing authorisation of Teva Pharmaceutical's Seasonique f2014/7/9
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GSK and Theravance announce Japanese approval for Anoro ElliptaGlaxoSmithKline (GSK) and Theravance have obtained approval from the Japanese Ministry of Health, Labour and Welfare for Anoro Ellipta to treat chronic obstructive pulmonary disease (COPD). The Japan2014/7/8
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Forest Laboratories completes acquisition of Furiex PharmaceuticalsActavis subsidiary Forest Laboratories has completed the acquisition of Furiex Pharmaceuticals, a US-based drug development collaboration company. Forest Laboratories has acquired Furiex in an all-ca2014/7/8