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GSK and Genmab receive European approval for ArzerraGlaxoSmithKline (GSK) and Genmab have received European Commission marketing authorisation for Arzerra as first-line treatment for chronic lymphocytic leukaemia in combination with chlorambucil or ben2014/7/7
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FDA grants priority review designation for Boehringer’s idiopathic pulmonary fibrosis therapyThe US Food and Drug Administration (FDA) has accepted the filing of Boehringer Ingelheim Pharmaceuticals' new drug application for its nintedanib and has granted priority review designation for treat2014/7/7
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Genentech to acquire Seragon PharmaceuticalsRoche Group member Genentech has entered into a definitive agreement to acquire the US-based biotechnology company Seragon Pharmaceuticals. Under the tagreement, Seragon Pharmaceuticals will receive2014/7/4
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Argentina approves Genzyme’s Lemtrada for multiple sclerosisSanofi subsidiary Genzyme has received approval from the Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) for its Lemtrada (alemtuzumab) for treatment of multiple scle2014/7/4
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Ipsen seeks US and European approvals for gastroenteropancreatic neuroendocrine tumour therapyIpsen has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) for approval of its Somatuline Depot 120mg injection for treatment of gastroenteropancreatic n2014/7/3
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Bristol-Myers Squibb receives CHMP’s positive opinion for EliquisThe European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorisation of Bristol-Myers Squibb and Pfizer's Eliqu2014/7/3
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GSK and Theravance submit supplemental new drug application to FDA for asthma treatmentGlaxoSmithKline (GSK) and Theravance have submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for a fixed dose combination of fluticasone furoate and vila2014/7/2
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Auxilium enters into definitive agreement to merge with QLTUS-based Auxilium Pharmaceuticals has entered into a definitive agreement to merge with Canadian biotechnology company QLT. Under the terms of the agreement, a wholly owned subsidiary of QLT will be2014/7/2
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Gilead seeks Japanese-clearance for chronic hepatitis C drugGilead Sciences has submitted a new drug application to Japan's Pharmaceutical and Medical Devices Agency (PMDA) for approval of its sofosbuvir for treatment of chronic hepatitis C virus (HCV) infecti2014/7/1
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FDA grants breakthrough therapy designation to Boehringer’s idarucizumabThe US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Boehringer Ingelheim Pharmaceuticals' idarucizumab, an investigational fully humanised antibody fragment bein2014/7/1