GlaxoSmithKline says FDA panel recommends approval of H5N1 flu vaccine GlaxoSmithKline announced that the U.S. Food and Drug Administrationís Vaccines and Related Biological Products Advisory Committee voted unanimously 14-0 that the safety and immunogenicity data of the H5N1 adjuvanted influenza vaccine candidate supports its licensure for the active immunisation for the prevention of disease in persons 18 years of age and older who are at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine. The VRBPAC provides the FDA with independent expert advice and non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. According to agency regulations, the FDA is scheduled to conclude its review for the vaccine in December 2012. If approved, the vaccine is to be used only according to official guidance from the U.S. Government.
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.