Guerbet SA: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
Provider: Reuters Investment Profile
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Guerbet SA Announces that Medical Imaging Drugs Advisory Committee Recommends Approval of Guerbet NDA for Dotarem
Guerbet SA announced that the Medical Imaging Drugs Advisory Committee to United States Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older. The Committee voted 10 to 6 (with one member abstaining) not to recommend at this time approval of the indication for children under two years of age.
Latest Developments for Guerbet SA
- Guerbet SA announces ANSM approval of Lipiodol Ultra-Fluid for visualization, localization and vectorization of hepatocellular carcinoma during trans-arterial chemoembolization
- Guerbet SA reaffirms FY 2014 revenue guidance
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- Guerbet SA proposes FY 2013 dividend and issues FY 2014 financial guidance
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