Related by context. Frequent words. (Click for all words.) 66 Marketing Authorization 63 Marketing Authorization Application MAA 62 Marketing Authorization Application 60 Orphan Drug status 58 European Medicines Evaluation 57 orphan designation 56 European Medicines Agency 56 Phase III Trial 56 Orphan Drug designation 55 orphan medicinal product 55 CHMP opinion 55 ATryn R 54 Complete Response 54 Icatibant 54 CHMP 53 Fast Track Designation 53 Clinical Trial 53 Complete Response letter 53 Rhucin ® 53 Swissmedic 53 Amigal 52 Clinical Trial Results 52 Orphan Drug Designation 52 Approvable Letter 52 Biologics License Application 52 Cladribine Tablets 52 Complete Response Letter 51 Orphan Medicinal Products 51 alvimopan 51 Toctino ® 51 Lenalidomide 51 REVLIMID R 51 Satraplatin 51 Clinical Study 51 TORISEL 51 Ceplene 51 Torisel 51 Neupro ® 51 tocilizumab 51 PROMACTA 50 BLA submission 50 Ceftobiprole 50 Special Protocol Assessment 50 Biologics License Application BLA 50 BioDelivery Sciences 50 sNDA 50 sBLA 50 Photocure 49 Santhera 49 taliglucerase alfa 49 Medicinal Products 49 Restanza 49 Fast Track designation 49 methylnaltrexone 49 Cimzia ® 49 Taxotere ® 49 Completes Enrollment 49 Mutual Recognition 49 L MTP PE 49 Rhucin 49 Jevtana 49 Loramyc ® 49 Vasovist 48 Zerenex 48 CE Marking 48 Cinryze TM 48 SEROQUEL XR 48 MOZOBIL 48 velaglucerase alfa 48 pralatrexate 48 Nexavar ® 48 Alemtuzumab 48 Orphan Drug 48 Investigational 48 refractory Hodgkin lymphoma 48 BENLYSTA 48 ThermoDox ® 48 Jerini 48 TYKERB 47 FDA Clearance 47 Shareholder Approval 47 Abstral 47 ceftobiprole 47 Priority Review 47 confirmatory Phase III 47 ADVEXIN 47 humanized anti 47 phase IIb 47 Keppra ® 47 Investigational Device Exemption IDE 47 Act PDUFA date 47 FDA Approval 47 REMICADE ® 47 vandetanib 47 Clolar 47 PREOS 47 VPRIV 47 Phenoptin 46 TOCOSOL Paclitaxel 46 Perifosine 46 Pixantrone