regulatory application

regulatory application

An application made to a health authority by a drug sponsor to investigate, market or license a new product or indication.
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M2 EQUITYBITES-July 22, 2015-Asahi Kasei Pharma's Xiaflex receives approval for regulatory application from the Japanese Pharmaceutical and Medical Device Agency
M2 PHARMA-July 22, 2015-Asahi Kasei Pharma's Xiaflex receives approval for regulatory application from the Japanese Pharmaceutical and Medical Device Agency
The company filed the regulatory application and allied environmental review for the planned Aspen project with the Alberta Energy Regulator and Alberta Environment and Sustainable Resource Development on Dec.
M2 EQUITYBITES-March 4, 2015-The German Federal Institute for Drugs and Medical Devices receives regulatory application for BioLineRx's Phase IIb trial of BL-8040
M2 PHARMA-March 4, 2015-The German Federal Institute for Drugs and Medical Devices receives regulatory application for BioLineRx's Phase IIb trial of BL-8040
today announced the submission of a regulatory application in the European Union for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD).
We look forward to gaining approvals of the product throughout Europe with our first regulatory application planned for Sweden within a month, followed by a number of other European applications.
M2 PHARMA-July 22, 2013-GW Pharmaceuticals plc files new marketing regulatory application to launch Sativex in France for the treatment of spasticity due to MS(C)2013 M2 COMMUNICATIONS
Ligand Pharmaceuticals Incorporated (Nasdaq: LGND), San Diego, has submitted a regulatory application to market its anti-cancer medicine ONZAR(TM) (denileukin diftitox) in the European Union for the treatment of cutaneous T-cell lymphoma (CTCL) patients.
M2 EQUITYBITES-July 23, 2013-GW Pharmaceuticals submits new Regulatory Application to expand the approval of Sativex into France(C)2013 M2 COMMUNICATIONS http://www.
M2 PHARMA-April 22, 2013-GSK and Theravance submit regulatory application for UMEC/VI in Japan(C)2013 M2 COMMUNICATIONS
M2 EQUITYBITES-July 22, 2013-GW Pharmaceuticals plc files new marketing regulatory application to launch Sativex in France for the treatment of spasticity due to MS(C)2013 M2 COMMUNICATIONS http://www.

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