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Bayer seeks EU marketing approval for aflibercept solution for injection to treat macular edemaBayer HealthCare has filed an application to the European Medicines Agency (EMA) seeking marketing approval for aflibercept solution for injection to treat patients with macular edema following branch2014/6/13
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EffRx Pharmaceuticals receives FDA orphan drug designation for EX404EffRx Pharmaceuticals has received US Food and Drug Administration (FDA) orphan-drug designation for its proprietary metformin-based product, EX404, for treatment of paediatric polycystic ovary syndro2014/6/12
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Immunomedics receives orphan drug designation for IMMU-132 to treat pancreatic cancerImmunomedics has received orphan drug designation from the US Food and Drug Administration's (FDA) Office of Orphan Products Development for its IMMU-132 for pancreatic cancer therapy. IMMU-132 is Im2014/6/12
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Merck to acquire Idenix Pharmaceuticals for $3.8bnMerck has reached a definitive agreement worth $3.85bn to acquire Idenix Pharmaceuticals, a biopharmaceutical firm specialising in the discovery and development of drugs for treating human viral disea2014/6/11
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Edison’s Vatiquinone receives FDA orphan drug status for Leigh syndromeInherited mitochondrial disease treatment specialists Edison Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its vatiquinone to treat Leigh synd2014/6/11
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Biogen Idec receives FDA approval for haemophilia A drugBiogen Idec has received approval from the US Food and Drug Administration (FDA) for its Eloctate to control and prevent bleeding episodes, perioperative management, as well as routine prophylaxis in2014/6/10
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Momenta Pharma receives FDA orphan drug designation for pancreatic cancer drugMomenta Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its necuparanib, a heparan sulfate mimetic indicated for treatment of pancreatic cancer.2014/6/10
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EMA accepts Boehringer Ingelheim’s marketing authorisation application for IPF drugBoehringer Ingelheim has announced that the European Medicines Agency (EMA) has validated and granted accelerated assessment for its marketing authorisation application for nintedanib for treatment of2014/6/9
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European Commission approves Invega for treatment of schizophrenia in adolescentsJanssen-Cilag International's Invega (paliperidone ER) has received the European Commission's approval to extend its adult indication for treatment of schizophrenia to include adolescents aged 15 year2014/6/9
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FDA grants orphan drug designation to ChemoCentryx’s CCX168ChemoCentryx has received orphan-drug designation from the US Food and Drug Administration (FDA) for its CCX168 for the treatment of anti-neutrophil cytoplasmic autoantibodies-associated vasculitides2014/6/6