Related by context. Frequent words. (Click for all words.) 75 sBLA 69 New Drug Application 68 Marketing Authorization Application MAA 67 Biologics License Application 67 Marketing Authorization Application 64 NDA submission 63 Clolar 62 Marqibo 60 Fast Track designation 60 approvable letter 60 clofarabine 59 PDUFA date 59 Drug Application 59 cutaneous T cell 59 investigational compound 58 BYDUREON 58 lubiprostone 58 L MTP PE 58 Phase Ib 57 Phase III clinical 57 fidaxomicin 57 monotherapy 57 ACTEMRA 57 ofatumumab 57 pivotal Phase III 57 Bronchitol 57 vandetanib 57 APF# 57 Rhucin 57 Zenvia 56 VYVANSE 56 BENLYSTA 56 Phase 2a trial 56 ABILIFY 56 resubmission 56 SEROQUEL 56 Ranexa 56 Kuvan 56 Phase 2b clinical 56 Entereg 56 Complete Response Letter 56 Exforge 56 oral formulation 55 Ceplene 55 Cimzia 55 FTY# 55 ISENTRESS 55 Trexima 55 Phase IIa trial 55 JANUVIA 55 pralatrexate 55 Galvus 55 Phase IIa 55 Phase 2b study 55 Fampridine SR 55 mg dose 55 Actemra 55 Aloxi 55 Xifaxan 55 Phase 2b trial 55 investigational oral 55 Phase 2b 55 vilazodone 55 ADDERALL XR 54 ONGLYZA 54 denufosol 54 TREANDA 54 Act PDUFA 54 INCB# [002] 54 Phase 2a clinical 54 Orphan Drug Designation 54 Investigational 54 Dyloject 54 Phase 1b 54 tablet formulation 54 HUMIRA 54 abatacept 54 CHMP 54 NGX# 54 Orphan Drug 54 FDA Approval 54 ZEVALIN 54 PRX # 54 GATTEX 54 FACTIVE 54 RG# [001] 54 Zerenex 54 Phase III clinical trials 54 ambrisentan 54 intravenous formulation 54 ANDAs 54 Priority Review 54 ZYBRESTAT 54 Xcytrin 53 FOSRENOL 53 ENBREL 53 Topical Interferon Alpha 2b 53 Intermezzo R 53 Phase IIb clinical 53 Drug Application ANDA 53 tamibarotene