Related by context. Frequent words. (Click for all words.) 53 APF# 52 Drug Application 51 Marketing Authorization Application MAA 50 New Drug Application 50 NDA submission 50 INCB# [002] 50 Satraplatin 49 Orphan Drug Designation 48 intravenous formulation 48 Marqibo 48 fidaxomicin 48 Phase 2b clinical 48 Phase IIb clinical 47 investigational drug 47 sNDA 47 Phase III clinical 47 FDA Approval 47 pivotal Phase III 47 Riquent 46 Phase 2b study 46 lubiprostone 46 CORLUX 46 Phase 2a clinical 46 satraplatin 46 FOSRENOL 46 Drug Application ANDA 45 pralatrexate 45 Entereg 45 Ceplene 45 Dyloject 45 Investigational 45 Phase IIb 45 Kuvan 45 Phase IIa trial 45 ADVEXIN 45 Phase III 44 investigational compound 44 Pennsaid 44 Phase IIa clinical 44 Zenvia 44 ANDAs 44 IND enabling 43 Bronchitol 43 investigational 43 RELISTOR 43 Phase III clinical trials 43 Fast Track designation 43 naproxcinod 43 Iluvien 43 Phase 2a 43 LibiGel 43 Phase Ib 42 cutaneous T cell 42 LEVADEX 42 orphan drug 42 orally administered 42 Phase III trials 42 Phase 2b trial 42 Phase IIa 42 pivotal Phase 42 linaclotide 41 AzaSite 41 Phase IIb trial 41 Dacogen 41 Act PDUFA 41 Phase 2b 41 ANDA 41 PDUFA date 41 New Drug IND 40 ceftobiprole 40 NovaDel 40 KRYSTEXXA 40 clofarabine 40 indiplon 40 Sucampo 40 Phase 1b 40 VYVANSE 40 Priority Review 40 XIAFLEX 40 IND 39 PRX # 39 Clolar 39 Antegren 39 approvable letter 39 CHMP 38 BioMimetic 38 Abbreviated New 38 initiate Phase 37 preclinical 37 Phase II 37 Shionogi 36 Drug Administration FDA 36 Qutenza 36 clinical trial 35 Complete Response Letter 35 Special Protocol Assessment 34 BLA 33 & JPRD 31 European Medicines Agency 31 resubmission 31 EpiCept