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 Home > GlaxoSmithKline Press Release > 2007  
GlaxoSmithKline Press Releases
21st September, 2007
GSK receives decision from FDA on Lamictal®XR™ Extended-Release Tablets
GSK receives decision from FDA on Lamictal®XR™ Extended-Release Tablets Issued: Friday 21 September 2007, Research Triangle Park, NC - GlaxoSmithKline (NYSE: GSK) announced today that the U.S ...
11th September, 2007
GlaxoSmithKline and Sepracor Inc. announce international alliance for commercilisation of Lunivia
GlaxoSmithKline and Sepracor Inc. announce international alliance for commercilisation of Lunivia GlaxoSmithKline (GSK) and Sepracor Inc. (Nasdaq: SEPR) today announced an agreement for the commercialisation of Sepracor’s eszopiclone product for all markets worldwide (excluding the U.S., Canada, Mexico and Japan) ...
11th September, 2007
GlaxoSmithKline responds to JAMA articles
GlaxoSmithKline responds to JAMA articles PHILADELPHIA, PA–September 11, 2007 - GlaxoSmithKline (NYSE: GSK) believes that conclusions drawn from the most recent meta-analyses published by Drs ...
4th September, 2007
Study shows combination therapy incorporating Avodart® and tamsulosin provides continuous symptom improvement over two years
Study shows combination therapy incorporating Avodart® and tamsulosin provides continuous symptom improvement over two years Issued — Tuesday 4 September 2007, London, UK - GlaxoSmithKline today announced new results from a large study that demonstrate combination treatment with Avodart® (dutasteride) and the alpha blocker, tamsulosin, provides significantly greater urinary symptom improvement for men with enlarged prostate than either Avodart or tamsulosin monotherapy over 24 months ...
3rd September, 2007
GlaxoSmithKline’s Arixtra® receives European authorisation for the treatment of acute coronary syndromes
GlaxoSmithKline’s Arixtra® receives European authorisation for the treatment of acute coronary syndromes Not for distribution to US Media Issued – Monday 3 September 2007, London, UK - GlaxoSmithKline announced today that the European Medicines Agency (EMEA) has authorised a new indication for its once-daily anticoagulant ARIXTRA® 2.5 mg (fondaparinux sodium) for the treatment of specific acute coronary syndromes (ACS) ...
28th August, 2007
FDA accepts for review complete response to approvable letter for Entereg®(Alvimopan) for POI
FDA accepts for review complete response to approvable letter for Entereg®(Alvimopan) for POI Adolor and GSK also submitted complete response to request the release of the clinical hold for INDs Issued – Tuesday 28 August 2007, London, UK, Exton & Philadelphia, US - GlaxoSmithKline and Adolor Corporation announced today that the US Food and Drug Administration (FDA) has accepted as complete, Adolor’s response to the November 2006 New Drug Application (NDA) approvable letter for Entereg® (alvimopan) for the management of postoperative ileus (POI) ...
28th August, 2007
GlaxoSmithKline receives approval for Atriance® (nelarabine) in Europe for the treatment of difficult-to-treat leukaemias and lymphomas
GlaxoSmithKline receives approval for Atriance® (nelarabine) in Europe for the treatment of difficult-to-treat leukaemias and lymphomas Not for distribution to US Media Issued: Tuesday 28 August 2007, London, UK - GlaxoSmithKline announced today that Atriance® (nelarabine solution for infusion) has received approval from the European Commission for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens.[1] “The approval of nelarabine for this orphan indication, addresses the real patient need that exists in these rare types of leukaemia and lymphoma”, said Andrew Witty, President, European Pharmaceuticals, GlaxoSmithKline ...
16th August, 2007
GlaxoSmithKline signs contract for its pandemic flu vaccine with UK Government
GlaxoSmithKline signs contract for its pandemic flu vaccine with UK Government Agreement forms part of UK Government’s pandemic preparedness plans Issued – Thursday 16 August 2007, London, UK - GlaxoSmithKline (GSK) today announced that it has entered into an agreement with the UK Government to provide its pandemic influenza vaccine in the event of a flu pandemic ...
14th August, 2007
GlaxoSmithKline’s application for Rotarix® is accepted for review by the FDA
GlaxoSmithKline’s application for Rotarix® is accepted for review by the FDA If approved, new candidate vaccine could offer completion of the rotavirus vaccination series by four months of age Philadelphia, PA (August 14, 2007) – GlaxoSmithKline (NYSE:GSK) today announced that the U.S ...
14th August, 2007
GlaxoSmithKline updates Prescribing Information for Avandia in the US
GlaxoSmithKline updates Prescribing Information for Avandia in the US PHILADELPHIA, PA (August 14, 2007) — GlaxoSmithKline [NYSE:GSK] today announced that the US Food and Drug Administration (FDA) has approved updated US prescribing information for the thiazolidinediones (TZD) class of medicines used in the treatment of Type 2 diabetes ...
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