Related by context. Frequent words. (Click for all words.) 83 Marketing Authorization Application 80 Marketing Authorization Application MAA 73 Marketing Authorization 72 Pivotal Phase III 71 Orphan Drug Status 71 Complete Response 70 Mutual Recognition Procedure 70 Phase III Clinical Trial 70 Pirfenidone 70 FIRAZYR 70 Biologics License Application BLA 70 orphan designation 69 Biologics License Application 69 sBLA 69 supplemental Biologics License Application 68 Orphan Drug designation 68 Abstral 68 Orphan Drug status 68 sNDA 67 Loramyc ® 67 Pivotal Trial 67 Nexavar ® 67 Cimzia ® 67 Phase III Trial 66 alvimopan 66 Icatibant 66 Avastin bevacizumab 66 Jevtana 66 Neupro 66 Drug Candidate 65 Hycamtin 65 BioDelivery Sciences 65 Onsolis 65 Amrubicin 64 NOXAFIL 64 Relistor 64 PREOS 64 cladribine 64 Flutiform 64 Orphan Drug Designation 64 REVLIMID R 64 silodosin 64 Clinical Trial Results 64 BLA submission 64 Rhucin 64 methylnaltrexone 64 Synvisc One 64 Rhucin ® 64 Ceftobiprole 64 REPLAGAL 63 European Medicines Evaluation 63 Scientific Advice 63 Taxotere ® 63 Santhera 63 New Drug Application 63 Pixantrone 63 Torisel 63 Neupro ® 63 ATryn R 63 Irinotecan 63 BEMA Fentanyl 63 TORISEL 63 REVLIMID ® 63 Fast Track Designation 63 LIALDA 63 orphan medicinal product 63 Replagal 63 Tygacil 63 diabetic neuropathic pain 63 Eloxatin R 63 pseudobulbar affect PBA 63 taliglucerase alfa 62 FDA Clearance 62 Phase IIa trial 62 Cladribine Tablets 62 Complete Response letter 62 Ventavis 62 Satraplatin 62 FDA Approval 62 Toctino ® 62 Ceplene 62 Pivotal Phase 62 Lenalidomide 62 Maraviroc 62 Swissmedic 62 Oscient Pharmaceuticals 62 Drug Application 62 Full Prescribing Information 62 UCB SA 62 ONSOLIS 62 roflumilast 62 Betaferon 62 Renvela 62 Avelox 62 Treanda 61 aztreonam lysine 61 Prescribing Information 61 SEROQUEL XR 61 CHMP opinion 61 Investigational Device Exemption IDE 61 Apricus Bio