Related by context. Frequent words. (Click for all words.) 76 NDA submission 72 Marketing Authorization Application MAA 69 sNDA 66 Investigational 62 New Drug IND 62 Marqibo 61 pivotal Phase III 61 Phase III clinical 61 Phase III clinical trials 60 approvable letter 58 IND 58 initiate Phase 57 Complete Response Letter 57 Phase 2b clinical 57 PRX # 57 Phase IIb clinical 57 Phase IIa trial 57 Phase IIb 56 Phase Ib 56 pivotal Phase 56 Phase 2b 56 Phase 2b study 56 Fast Track designation 56 Phase III 56 Phase 2b trial 56 Phase IIa 56 Drug Application 55 investigational 55 Orphan Drug Designation 55 Pennsaid 55 investigational compound 55 resubmission 55 satraplatin 55 Ceplene 55 Phase IIa clinical 55 Iluvien 55 PDUFA date 54 Phase IIb trial 54 Phase 2a clinical 54 Drug Administration FDA 54 IND enabling 54 APF# 53 ANDAs 53 Phase 2a 53 Phase III trials 53 linaclotide 53 Abbreviated New 53 CORLUX 53 indiplon 53 investigational drug 53 Bronchitol 53 ANDA 52 BLA 52 Phase 1b 52 Dyloject 52 lubiprostone 52 Kuvan 52 AzaSite 52 Drug Application ANDA 52 clofarabine 52 fidaxomicin 52 Satraplatin 51 FDA Approval 51 Dacogen 51 orally administered 51 ADVEXIN 51 European Medicines Agency 51 Clolar 51 Qutenza 51 KRYSTEXXA 51 intravenous formulation 51 EpiCept 50 Shionogi 50 VYVANSE 50 Act PDUFA 50 LEVADEX 50 clinical trial 50 Antegren 50 Phase II 50 BioMimetic 50 XIAFLEX 50 preclinical 50 cutaneous T cell 50 Zenvia 50 Sucampo 50 Special Protocol Assessment 50 CHMP 50 INCB# [002] 50 Priority Review 49 LibiGel 49 orphan drug 49 pralatrexate 49 FOSRENOL 49 RELISTOR 49 Riquent 49 NovaDel 49 Entereg 49 & JPRD 49 ceftobiprole 49 naproxcinod 49 transdermal patch