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Related Topics >> FDA | GlaxoSmithKline | Cervarix

FDA tells Glaxo to wait on Cervarix decision

GlaxoSmithKline will have to continue to be patient with its application to sell the HPV vaccine Cervarix in the U.S. The pharma giant says the FDA told the company it will miss its Tuesday deadline as regulators take more time to review the application. Cervarix is approved for use in more than 100 countries and was recently endorsed by an expert FDA panel, leaving a number of analysts confident of the FDA's approval. Glaxo says it is confident as well and expects a decision soon. Report


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