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Alcobra seeks FDA's IND approval for Metadoxine extended-release to treat ADHDIsraeli biopharmaceutical company Alcobra has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to start a Phase III clinical trial with its proprietary2014/2/11
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Omeros' Huntington's drug OMS824 gets FDA fast-track statusOmeros has received fast-track designation from the US Food and Drug Administration (FDA) for its phosphodiesterase 10 (PDE10) inhibitor 'OMS824' to treat cognitive impairment in patients with Hunting2014/2/11
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NIH Study Finds Regular Aspirin use May Reduce Ovarian Cancer RiskWomen who take aspirin daily may reduce their risk of ovarian cancer by 20%, according to a study by scientists at the National Cancer Institute (NCI), part of theNational Institutes of Health. Howeve2014/2/10
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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