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June 14, 2015
March 15, 2015
June 30, 2014
Second CRL for the migraine aerosol therapy
March 27, 2014
Says safety and efficacy concerns have been addressed
February 17, 2014
J&J's Janssen received two complete response letters
January 01, 2014
FDA calls for new comparator studies to prove benefit over risk
September 24, 2013
Merck working with FDA to resolve issues
March 06, 2013
US regulators have again knocked back Janssen Research & Development's application to extend the label for the blood thinner Xarelto.
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.
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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