Related by context. Frequent words. (Click for all words.) 83 Orphan Drug designation 80 Orphan Medicinal Product 78 Fast Track Designation 78 orphan medicinal product 78 Orphan Drug Status 77 orphan designation 76 Orphan Drug Designation 74 Orphan Drug 73 Fast Track designation 72 orphan drug 71 granted orphan 70 Marketing Authorization 70 granted Orphan Drug 68 Amrubicin 68 Marketing Authorization Application 68 Icatibant 67 Positive Opinion 66 Medicinal Products EMEA 66 Torisel 66 supplemental Biologics License Application 66 FIRAZYR 66 Pirfenidone 65 Lenalidomide 65 Pivotal Phase III 65 Priority Review 65 Mutual Recognition Procedure 64 ATryn ® 64 Marketing Authorization Application MAA 64 methylnaltrexone 64 Nexavar ® 64 Nimotuzumab 63 ATryn R 63 Onalta 63 alvimopan 63 Clevudine 63 Investigational Device Exemption 63 European Medicines Evaluation 63 TORISEL 62 anticancer compound 62 mTOR inhibitor 62 Everolimus 62 taliglucerase alfa 62 Genasense R 62 Phase III Clinical Trial 62 Azedra 62 romidepsin 62 clofarabine 62 Hycamtin 62 Jevtana 61 ThermoDox ® 61 pediatric exclusivity 61 Irinotecan 61 REVLIMID R 61 tamibarotene 61 registrational 61 Diamyd ® 61 silodosin 61 temsirolimus 61 Rhucin ® 61 AA amyloidosis 61 Pivotal Trial 61 ELND# 61 thymalfasin 61 registrational trial 61 Loramyc ® 61 granted Fast Track 61 Cladribine Tablets 61 oncology indications 61 Avastin bevacizumab 61 Toctino R 60 Satraplatin 60 Pixantrone 60 pseudobulbar affect PBA 60 Scientific Advice 60 tocilizumab 60 ADVEXIN 60 PROMACTA 60 CHMP opinion 60 gastrointestinal stromal tumors 60 metastatic hormone refractory 60 IRESSA 60 Vasovist 60 HIV protease inhibitor 60 Drug Candidate 60 Carfilzomib 60 Biologics License Application 60 Swissmedic 60 ZALBIN 60 BLA submission 60 ELAPRASE 60 CE Marked 60 NEUMUNE 60 Abstral 60 Perifosine 60 Virulizin R 60 atacicept 59 humanized monoclonal antibody 59 pancreatic insufficiency 59 Telavancin 59 USFDA approval 59 Toctino ®