Related by context. Frequent words. (Click for all words.) 62 PMA submission 60 Market Approval PMA 59 Biologics License Application BLA 58 FDA Accepts 58 Complete Response 57 Investigational Device Exemption IDE 57 Investigational Device Exemption 57 Biologics License Application 56 FDA Clearance 56 Marketing Authorization Application 56 supplemental Biologics License Application 56 Clinical Trial Application 55 Marketing Authorization Application MAA 55 application sNDA 55 Pivotal Phase III 55 Application BLA 55 IND submission 55 FDA approvable letter 54 IND 54 Combidex 54 Marketing Authorisation 53 Orphan Drug Status 53 Initiate Phase 53 License Application 53 Application MAA 53 FDA Complete Response 53 exemption IDE 52 Ixempra 52 Humanitarian Device Exemption 52 Junovan 52 VALSTAR 52 submitted Biologics License 52 Phase III Clinical Trial 52 INDs 52 nonclinical studies 52 sBLA 52 Excellagen 52 IMC #B 51 BLA submission 51 Complete Response letter 51 Panzem R 51 GLPG# 51 Solzira 51 PREOS 51 CORTOSS 51 refractory chronic lymphocytic 51 Phase Ib II 51 Drug Candidate 51 VIAject 51 Augment Bone Graft 50 Orphan Drug status 50 MHLW 50 ROTATEQ 50 Guanilib 50 #nm Hi 50 SFDA approval 50 Omigard 50 ISTODAX 50 subcutaneous formulation 50 Phase IIB 50 PEG SN# 50 BioSilicon TM 49 anticancer compound 49 M Enoxaparin 49 MORAb 49 ATryn ® 49 orphan designation 49 Drug Applications ANDAs 49 submitted Marketing Authorization 49 Fusilev 49 apaziquone 49 Ceragenix 49 Phase Ib clinical 49 Paragraph IV 49 OTCQX RHHBY 49 registrational 49 IoGen 49 BrachySil 49 Factor VIIa 49 Zelrix 49 Onko Sure ® 49 Cotara R 49 Clevudine 49 ixabepilone 49 Kiadis Pharma 48 Icatibant 48 Belinostat 48 ATL# [001] 48 Australian Therapeutic Goods 48 IMPAX Laboratories Inc. 48 ABRAXANE ® 48 Drug Administration KFDA 48 deforolimus 48 Drug Administration FDA 48 Investigational 48 Urocidin 48 registrational trial 48 Pivotal Phase 48 Nasdaq ENZN 48 FavId 48 HCV protease inhibitor