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Rempex obtains $90m BARDA contract for development of gram-negative antibioticThe Medicines Company subsidiary Rempex Pharmaceuticals has received a contract worth $90m from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of Carbava2014/2/10
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FDA grants breakthrough therapy status to GSK's anaemia drug eltrombopagThe US Food and Drug Administration (FDA) has granted breakthrough therapy designation for GlaxoSmithKline's (GSK) Promacta/Revolade (eltrombopag) for the treatment of cytopenias in patients with seve2014/2/8
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Biogen's multiple sclerosis drug Tecfidera obtains EU approvalUS-based Biogen Idec has received approval from the European Commission (EC) for its Tecfidera (dimethyl fumarate) as a first-line oral treatment for people with relapsing-remitting multiple scleros2014/2/8
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US FDA approves Vanda's sleep disorder drugThe US Food and Drug Administration (FDA) has approved Vanda Pharmaceuticals' HETLIOZ (tasimelteon) 20mg capsules for treatment of non-24-hour sleep-wake disorder (non-24). HETLIOZ is the first FDA a2014/2/7
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Genzyme obtains Mexican approval for multiple sclerosis drug LemtradaSanofi subsidiary Genzyme has received approval from Mexico's national regulatory authority COFEPRIS for its Lemtrada (alemtuzumab) to treat patients with relapsing remitting forms of multiple scleros2014/2/7
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Teva secures FDA approval for new formulation of COPAXONEIsrael-based Teva Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for three-times-a-week COPAXONE 40mg/mL, a new d2014/1/30
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Merck Statement on FDA Advisory Committee Meeting for RAGWITEK, an Investigational Sublingual Allergy Immunotherapy TabletMerck, known as MSD outside the US and Canada, is pleased with the positive discussion of RAGWITEK (Short Ragweed Pollen Allergen Extract) at the Allergenic Products Advisory Committee meeting of FDA.2014/1/30
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EMA panel issues positive opinion for DSP and Takeda's schizophrenia drug lurasidoneJapanese firms Dainippon Sumitomo Pharma (DSP) and Takeda Pharmaceutical (Takeda) have received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human U2014/1/29
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Apricus gets national phase approval in Belgium for erectile dysfunction cream VitarosUS-based pharmaceutical firm Apricus Biosciences has received national phase approval from Belgium's Ministry of Social Affairs, Public Health and Environment for Vitaros, indicated for the treatment2014/1/29
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FDA Prohibits Ranbaxy’s Toansa, India Facility from Producing and Distributing Drugs for the US MarketFDA hasnotified Ranbaxy Laboratories, Ltd, that it is prohibited from manufacturing and distributing APIs from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is no2014/1/28