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AstraZeneca and MRC Enter Strategic Collaboration to Create New Centre for Early Drug Discovery in Cambridge, UKAstraZeneca and the Medical Research Council (MRC) have entered into a groundbreaking collaboration aimed at better understanding the mechanisms of human disease. The collaboration will see the creati2014/4/1
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US FDA accepts Avanir's NDA for AVP-825 to treat migrainesThe US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals' new drug application (NDA) of its breath-powered investigational drug-device combination product AVP-825 for the acute tr2014/4/1
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EMA validates Gilead’s marketing application for hepatitis C combination drugThe European Medicines Agency (EMA) has fully validated Gilead Sciences' marketing authorisation application (MAA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg a2014/3/31
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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