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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
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Sanofi Pasteur and SK Chemical to jointly develop pneumococcal conjugate vaccineSanofi Pasteur, the vaccines division of French pharmaceutical firm Sanofi, has entered into a long-term strategic cooperation with SK Chemicals to jointly develop a new pneumococcal conjugate vaccine2014/3/24
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FDA approves Pierre Fabre's paediatric drug Hemangeol to treat infantile hemangiomaThe US Food and Drug Administration (FDA) has granted marketing authorisation to Pierre Fabre's paediatric drug Hemangeol (propranolol hydrochloride), as the first and only approved treatment for prol2014/3/21
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ThromboGenics' vitreomacular traction drug Jetrea gets approval in SwitzerlandBelgium-based biopharmaceutical firm ThromboGenics has received approval from the Swiss Agency for Therapeutic Products, Swissmedic, for Jetrea (ocriplasmin) to treat adults with vitreomacular tractio2014/3/21
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Merck's NOXAFIL injection secures US FDA approvalThe US Food and Drug Administration has approved Merck's antifungal agent NOXAFIL (posaconazole) injection (18mg/ mL), a new formulation for intravenous (IV) use. The antifungal agent is also markete2014/3/20