The US Food and Drug Administration (FDA) has approved a new 4-strain seasonal flu vaccine from GlaxoSmithKline plc (GSK), the company announced on Monday. Fluarix Quadrivalent is approved for use in adults, plus children aged 3 and over, to protect them from disease caused by influenza virus...
Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that GlaxoSmithKline (GSK) has initiated two separate Phase 2b trials of GSK 2251052, or GSK '052 (formerly referred to as AN3365), in complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). GSK '052 is...
GlaxoSmithKline (NYSE and LSE: GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has announced their individual regulatory decisions and the resulting actions. In the...
The Bone and Joint Decade (BJD) international initiative and GlaxoSmithKline (GSK) announced the launch of the LIBERATE™ joint pain management programme during the BJD's World Conference in Lund, Sweden. The BJD, which is endorsed by the United Nation's World Health Organisation, and GSK have...
GSK (NYSE: GSK) has become one of the first manufacturers to sign a unique agreement with the GAVI Alliance (GAVI) that has the potential to save millions of children from dying in the world's poorest countries. GSK will supply up to 300 million doses of its vaccine Synflorix, for invasive...
The WHO on Monday advised developing countries to continue administering GlaxoSmithKline's Rotarix vaccine - which offers protection to children against the diarrhea-causing rotavirus - after the FDA advised doctors in the U.S. to temporarily stop using the vaccine following the discovery that...
Drug maker GlaxoSmithKline (GSK) "plans to bolster earnings by selling to more people in middle-income countries after cutting prices in the world's poorest nations," Bloomberg/BusinessWeek reports. "Our strategy is to grow our business in middle-income countries by increasing the volume of...
GlaxoSmithKline is reviewing label changes proposed by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK's Advair (salmeterol / fluticasone propionate). GSK and makers of the other affected medicines containing LABAs have...
GlaxoSmithKline (GSK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued two positive opinions in the European Union for two of its cancer medicines. The CHMP has issued a positive opinion for the authorisation of a new therapeutic...
GlaxoSmithKline is reviewing label changes proposed by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK's Advair (salmeterol / fluticasone propionate). GSK and makers of the other affected medicines containing LABAs have...
GlaxoSmithKline (GSK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued two positive opinions in the European Union for two of its cancer medicines. The CHMP has issued a positive opinion for the authorisation of a new therapeutic...
GlaxoSmithKline is reviewing label changes proposed by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK's Advair (salmeterol / fluticasone propionate). GSK and makers of the other affected medicines containing LABAs have...
GlaxoSmithKline (GSK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued two positive opinions in the European Union for two of its cancer medicines. The CHMP has issued a positive opinion for the authorisation of a new therapeutic...
GSK announces the formation of a new standalone unit specialising in the development and commercialisation of medicines for rare diseases. Over 5,500 rare diseases have been identified(1) of which less than 10% are currently being treated(2), presenting a significant unmet medical need. Despite...
GSK Head Discusses Company Interest In NTDs The Associated Press features a Q&A with GlaxoSmithKline (GSK) CEO Andrew Witty, who "is pushing to sell more products in fast-growing 'emerging markets' such as Brazil, Russia, India and China" while simultaneously "increasing efforts to bring...