Related by context. Frequent words. (Click for all words.) 71 orphan designation 70 Orphan Drug status 70 Marketing Authorization Application MAA 69 Marketing Authorization Application 69 Orphan Drug designation 68 orphan medicinal product 67 Orphan Drug Designation 66 Scientific Advice 64 Ceftobiprole 64 Icatibant 64 CHMP opinion 63 Loramyc ® 63 European Medicines Evaluation 62 Rhucin ® 62 Fast Track Designation 62 CE Marking 62 Vasovist 62 Neupro 61 FOSRENOL 61 methylnaltrexone 61 pediatric exclusivity 61 Keppra ® 61 Biologics License Application 61 Tygacil 61 REPLAGAL 60 Abstral 60 Rhucin 60 ceftobiprole 60 Swissmedic 60 Complete Response 60 Orphan Drug 60 Drug Application 59 Toctino ® 59 taliglucerase alfa 59 Ilaris 59 Oral Solution 59 Phase III Trial 59 Cimzia ® 59 Arixtra 59 European Medicines Agency 59 Citizen Petition 59 ATryn R 58 Aclasta 58 Cimzia R 58 Relistor 58 Ceplene 58 RELISTOR 58 alvimopan 58 Synvisc One 58 PhosLo 58 GI GVHD 58 Biologics License Application BLA 58 Replagal 58 Torisel 58 Santhera 58 ELAPRASE 58 Priority Review 58 ONSOLIS 58 FDA Approval 57 PROMACTA 57 VPRIV 57 CHMP 57 BENLYSTA 57 Fast Track designation 57 Omnitrope 57 Nexavar ® 57 Onsolis 57 XGEVA 57 clofarabine 57 Ondansetron 57 BioDelivery Sciences 57 Vimpat ® 57 BioAlliance 57 TORISEL 57 Regulatory Approval 57 Jevtana 57 sBLA 56 Neupro ® 56 Cayston 56 Photocure 56 Alemtuzumab 56 Ceplene R 56 Ventavis 56 Nasal Spray 56 TYKERB 56 Prescribing Information 56 Pixantrone 56 velaglucerase alfa 56 Rifaximin 56 Nimotuzumab 56 Vimpat 56 Orexo 56 Avastin bevacizumab 56 Protopic 56 LIALDA 56 Drug Candidate 56 Docetaxel 56 PEG INTRON 56 Jerini 56 Approvable Letter 55 Swedish Orphan Biovitrum