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1 October 2014 | By Daiichi Sankyo
Daiichi Sankyo Company Limited announced that it and its domestic generic subsidiary, Daiichi Sankyo Espha Co., Ltd. have submitted a supplemental New Drug Application (sNDA) in Japan...
14 July 2014 | By Teva
First breath-actuated dry-powder SABA inhaler to be accepted by FDA for review...
14 May 2014 | By Johnson & Johnson
Janssen Pharmaceuticals, Inc., announced the submission of supplemental New Drug Applications for once-monthly atypical long-acting antipsychotic INVEGA® SUSTENNA® (paliperidone palmitate) to the U.S. Food and Drug Administration...
9 January 2014 | By Daiichi Sankyo
Submission based on the two largest comparative phase 3 clinical trials of a novel oral anticoagulant in patients with non-valvular atrial fibrillation or symptomatic venous thromboembolism...
19 December 2013 | By Daiichi Sankyo Company
Daiichi Sankyo is seeking approval in Japan for edoxaban in new indications for non-valvular atrial fibrillation (AF) and symptomatic venous thromboembolism...
24 June 2010 | By Michael J. Miller, Ph.D., President, Microbiology Consultants, LLC
This is the third in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order…
