Related by context. Frequent words. (Click for all words.) 57 Positive Opinion 56 Orphan Drug designation 56 Marketing Authorization 56 Orphan Drug status 55 Mutual Recognition Procedure 55 Ceplene R 55 Orphan Medicinal Product 54 orphan designation 54 FIRAZYR 54 orphan medicinal product 54 Marketing Authorization Application 54 alvimopan 53 Rhucin ® 52 Icatibant 52 ATryn ® 52 GEM #S 52 Clevudine 51 Marketing Authorization Application MAA 51 granted Orphan Drug 51 Scientific Advice 51 Swissmedic 51 Cinryze TM 51 ATryn R 51 OFIRMEV 51 ZALBIN 50 Orphan Drug Status 50 European Medicines Evaluation 50 Phase III Trial 50 Exalgo 50 Vasovist 49 Investigational Device Exemption 49 Ceplene ® 49 FavId 49 aztreonam lysine 49 Abstral 49 Loramyc ® 49 granted orphan 49 Esbriet 48 Orphan Drug Designation 48 BLA submission 48 Rosetta dependence 48 oral calcitonin 48 Pivotal Phase III 48 Phase III Clinical Trial 48 Phase IIa clinical trials 48 Omigard 48 SILENOR TM 47 BENLYSTA 47 apaziquone 47 PREOS 47 supplemental Biologics License Application 47 ONTAK 47 regulatory approval 47 ELAPRASE 47 Cladribine Tablets 47 orphan drug 47 Allovectin 7 R 47 Cladribine 47 THELIN 47 methylnaltrexone 46 Ceftobiprole 46 CHMP opinion 46 authorizations 46 Fast Track Designation 46 confirmatory Phase III 46 Zelrix 46 BEMA Fentanyl 46 authorization 46 taliglucerase alfa 46 Regulatory Approval 46 REPLAGAL 46 CHMP 46 Receives CE 46 Phenoptin 46 SANCTURA R 45 JZP 6 45 granted Fast Track 45 Vitaros 45 tetrabenazine 45 Receives Positive 45 Rhucin 45 NEBIDO 45 exemption IDE 45 MOZOBIL 45 Approvable Letter 45 Biologics License Application 45 autoimmune indications 45 valopicitabine 45 ambrisentan 45 BrachySil 45 sBLA 44 pediatric exclusivity 44 Jet Management EJM 44 Fast Track designation 44 Human Genetic Therapies 44 vernakalant iv 44 Biologics License Application BLA 44 Neuromed 44 approval 44 CE Marked 44 pralatrexate