Related by context. Frequent words. (Click for all words.) 67 Fast Track Designation 67 Orphan Drug designation 67 Orphan Drug Designation 65 Orphan Drug status 64 Complete Response 64 orphan designation 63 Fast Track designation 63 orphan drug 62 Act PDUFA date 62 orphan medicinal product 61 Marketing Authorization Application 60 Biologics License Application 60 Orphan Drug 60 Approvable Letter 59 Prescription Drug User Fee 59 Biologics License Application BLA 59 granted orphan 58 Torisel 58 Jevtana 58 European Medicines Evaluation 58 Marketing Authorization 57 granted Orphan Drug 57 Cladribine Tablets 57 Act PDUFA 57 PROMACTA 56 BENLYSTA 56 sBLA 56 TORISEL 55 eltrombopag 55 PDUFA date 55 pediatric exclusivity 55 ATryn R 55 PDUFA 55 Marketing Authorization Application MAA 55 alvimopan 55 Rhucin ® 54 Pixantrone 54 sNDA 53 granted Fast Track 53 Nexavar ® 53 Clolar 53 k Clearance 53 Bronchitol 52 azacitidine 52 Promacta 52 REVLIMID R 52 NUVIGIL 52 Kuvan 52 velaglucerase alfa 52 temsirolimus 52 Marqibo 52 Cimzia ® 52 ADVEXIN 52 LIALDA 52 Vilazodone 52 FDA Approval 52 FTY# 52 Bevacizumab 52 VPRIV 52 JANUVIA 52 Qualifying Therapeutic Discovery 51 ustekinumab 51 APF# 51 SEROQUEL XR 51 vilazodone 51 Tygacil 51 vandetanib 51 BioDelivery Sciences 51 Phenoptin 51 cladribine 51 Complete Response Letter 51 taliglucerase alfa 51 Taxotere ® 51 iloperidone 51 Research CDER 51 Phase III Trial 50 Oral Suspension 50 VIDAZA 50 Mozobil 50 XGEVA 50 Ampligen 50 approvable letter 50 Stelara 50 CHMP opinion 50 ANDAs 50 Complete Response letter 50 tocilizumab 50 ATryn 50 Final Approval 50 Treanda 50 clofarabine 50 Exalgo 50 ambrisentan 50 Vidaza 50 Cethrin 50 Relistor 50 Peramivir 50 Horizant 50 New Drug Application 49 VIBATIV 49 Rifaximin