GlaxoSmithKline receives positive CHMP opinion for diabetes drug GlaxoSmithKline announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending marketing authorization for albiglutide. The CHMP opinion concerns albiglutide proposed as a once-weekly treatment to improve glycaemic control in adult patients with type 2 diabetes. Albiglutide is currently undergoing review by other authorities, including the FDA, where the U.S. Prescription Drug User Fee Act target date is April 15. Albiglutide is not approved for use anywhere in the world.
News For GSK From The Last 14 Days
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Ligand says partner GSK submits application for Promacta Ligand Pharmaceuticals (LGND) said its partner GlaxoSmithKline (GSK) announced today the submission of a supplemental New Drug Application to the FDA for Promacta for the treatment of cytopenias in patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy.