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Company Profile


European Medicines Agency (EMA) 

7 Westferry Circus
Canary Wharf
London    E14 4HB  United Kingdom
Phone: 44-0-20-7523-7600 Fax: n/a



Company News
Boehringer Ingelheim Release: Company's Biosimilar Candidate To Humira® Accepted For EMA And FDA Regulatory Review 1/18/2017 7:43:11 AM
Aralez Submits Marketing Authorization Application To The EMA For PA10040 1/9/2017 7:30:20 AM
Soligenix (SNGX) Receives Positive Scientific Advice From The EMA For SGX942 In The Treatment Of Oral Mucositis In Head And Neck Cancer Patients 1/5/2017 8:52:28 AM
TiGenix Submits Day 120 Responses To EMA For Cx601 Marketing Authorization 12/27/2016 8:57:42 AM
Portola (PTLA) Announces FDA Accepts New Drug Application For Priority Review And EMA Validates Marketing Authorization Application For Oral, Factor Xa Inhibitor Anticoagulant Betrixaban 12/27/2016 7:49:21 AM
Sarepta (SRPT) Announces EMA Validation Of Eteplirsen Authorization Application For Treatment Of Duchenne Muscular Dystrophy Amenable To Exon Skipping 51 12/20/2016 1:00:54 PM
Juno (JUNO)’ And Celgene (CELG)’s Investigational Drug JCAR017 Granted Breakthrough Therapy Designation From FDA And Priority Medicines Eligibility From EMAFor Relapsed/Refractory Diffuse Large B-Cell Lymphoma 12/20/2016 12:13:45 PM
EMA’s CHMP Recommends Merck & Co. (MRK)’s KEYTRUDA (Pembrolizumab) For The First-Line Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Have High PD-L1 Expression With No EGFR Or ALK Positive Tumor Mutations 12/16/2016 11:33:54 AM
Neurotrophic Keratitis: EMA Validates The Marketing Authorisation Application For Cenegermin Eye Drops (Oxervate) Submitted By Dompe 12/12/2016 8:44:05 AM
Regeneron (REGN) And Sanofi (SNY)i Announce Marketing Authorization Application For Dupixent (Dupilumab) Accepted For Review By The EMA 12/8/2016 8:10:29 AM