Related by context. Frequent words. (Click for all words.) 70 Marketing Authorization Application 68 Marketing Authorization Application MAA 64 Rhucin ® 63 Orphan Drug status 62 Biologics License Application BLA 62 CHMP opinion 61 Mutual Recognition Procedure 60 supplemental Biologics License Application 60 Biologics License Application 60 FIRAZYR 59 Pivotal Phase III 59 orphan designation 59 Marketing Authorization 59 European Medicines Evaluation 58 Pirfenidone 57 alvimopan 57 orphan medicinal product 57 ATryn ® 57 Act PDUFA date 56 Scientific Advice 56 Orphan Drug designation 56 Icatibant 56 BENLYSTA 56 Investigational Device Exemption 56 Orphan Medicinal Product 56 Nexavar ® 56 aztreonam lysine 56 ATryn R 55 Amrubicin 55 relapsed refractory multiple myeloma 55 registrational 55 Jevtana 55 Complete Response letter 55 Orphan Drug Status 55 Phase III Clinical Trial 54 Hepatitis C HCV 54 Rhucin 54 ecallantide 54 pseudobulbar affect PBA 54 FavId 54 Rifaximin 53 sNDA 53 Cinryze TM 53 refractory peripheral T 53 Complete Response 53 Reader Comment Guidelines 53 Esbriet 53 Abstral 53 BLA submission 53 metastatic hormone refractory 53 Toctino ® 53 Ceftobiprole 53 Cimzia ® 53 image above.Error No 53 IND submission 53 lymphoma CTCL 53 Torisel 53 Investigational Device Exemption IDE 52 Phase III Trial 52 maribavir 52 velaglucerase alfa 52 Loramyc ® 52 Ceplene 52 Fast Track designation 52 Orphan Drug Designation 52 sBLA 52 silodosin 52 Replagal 52 registrational trial 52 confirmatory Phase 3 52 Completes Enrollment 52 TORISEL 52 Oscient Pharmaceuticals Corporation 52 REPLAGAL 52 Restanza 52 Taxotere ® 52 diabetic peripheral neuropathic pain 52 Ofatumumab 52 Pivotal Trial 52 REVLIMID R 52 taliglucerase alfa 52 ofatumumab 51 sodium Injection 51 bazedoxifene 51 Swissmedic 51 Fast Track Designation 51 cervical cancer vaccine Cervarix 51 Virulizin R 51 Avastin bevacizumab 51 confirmatory Phase III 51 Phase III pivotal 51 Pivotal Phase 51 Promacta 51 MOZOBIL 51 ADVEXIN 51 Staccato loxapine 51 Phenoptin 51 eltrombopag 50 Zelrix 50 NOXAFIL 50 Ceplene R