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US FDA approves Actavis-Valeant's NDA for Metronidazole 1.3% vaginal gelThe US Food and Drug Administration (FDA) has approved Actavis-Valeant's new drug application (NDA) for Metronidazole 1.3% vaginal gel, an antibiotic for treatment of bacterial vaginosis (BV). Approv2014/3/31
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European Commission approves GSK's diabetes drug EperzanThe European Commission (EC) has granted marketing approval for GlaxoSmithKline's (GSK's) once-weekly diabetes drug albiglutide, which is marketed as Eperzan. The drug is indicated for treatment of t2014/3/28
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Otsuka's kidney drug Samsca receives approval in JapanOtsuka Pharmaceutical has received regulatory approval from Japanese authorities for Samsca for a pharmacological treatment of autosomal dominant polycystic kidney disease (ADPKD). The approval is fo2014/3/28
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New study identifies possible therapeutic targets for organ transplantationA recent study conducted by Dr Nuria Lloberas from Barcelona's Hospital Universitario de Bellvitge, with Astellas European Foundation Grant support, has identified potential therapeutic targets for tr2014/3/27
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FDA approves Celgene's oral therapy OTEZLA for treatment of psoriatic arthritisCelgene has received approval from the US Food and Drug Administration (FDA) for its oral, selective inhibitor of phosphodiesterase 4 (PDE4) 'OTEZLA (apremilast)' as a treatment for adult patients wit2014/3/27
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Pfizer's vaccine candidate bivalent rLP2086 obtains breakthrough status from FDAThe US Food and Drug Administration (FDA) has granted breakthrough therapy status to Pfizer's vaccine candidate, bivalent rLP2086, currently being investigated for the prevention of invasive meningoco2014/3/26
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Takeda's NDA of hypertension drug Zacras approved in JapanThe Japanese Ministry of Health, Labour and Welfare has approved Takeda Pharmaceutical's new drug application (NDA) of Zacras tablets, a fixed-dose combination (FDC) of azilsartan (generic name) and a2014/3/26
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Forxiga Receives Regulatory Approval in Japan for the Treatment of Type 2 DiabetesAstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Forxiga (dapagliflozin in 5 and 10 mg tablets), a sodium-glucose cotransporter 2 (SGLT2) inhibitor,2014/3/25
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Biogen's haemophilia B therapy Alprolix approved in CanadaUS-based Biogen Idec has received approval from Health Canada for Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein], for the control and prevention of bleeding episodes and routine pro2014/3/25
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Five Prime and BMS partner to discover new immuno-oncology therapiesFive Prime Therapeutics and Bristol-Myers Squibb (BMS) have signed an agreement to discover, develop and commercialise immuno-oncology therapies directed toward targets identified in two undisclosed i2014/3/24