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March 06, 2013
US regulators have again knocked back Janssen Research & Development's application to extend the label for the blood thinner Xarelto.
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June 22, 2012
There was bad news for Bayer yesterday (Thursday) after the US Food and Drug Administration turned down an additional indication for its Johnson & Johnson-partnered blood thinner Xarelto.
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April 30, 2012
Global biotechnology giant has suffered a setback after US regulators rejected expanded use for Xgeva. Elsewhere, the firm said it plans to invest at least $200m in expanding it production facilities in Dun Laoghaire, Ireland.
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March 21, 2011
As anticipated, the US Food and Drug Administration has turned down Eli Lilly's novel imaging agent Amyvid over fears that experts may not interpret the brain scans in a consistent way.
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March 09, 2011
Salix Pharmaceuticals' antibiotic Xifaxan has failed to win favour with the US Food and Drug Administration for the treatment of irritable bowel syndrome.
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February 02, 2011
Orexigen Therapeutics' stock collapsed yesterday after US regulators turned away its weight loss drug Contrave, requesting a lengthy and expensive additional trial.
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January 31, 2011
Arena Pharmaceuticals saw its shares sink 15% as further details surrounding its response to the FDA's rejection of its weight management drug lorcaserin emerged alongside news of a 25% cull of its workforce to save cash
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December 15, 2010
Vivus said yesterday that it has responded to the US Food and Drug Administration’s complete response letter regarding its application to market Qnexa as a treatment for obesity and weight loss.
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