Related by context. Frequent words. (Click for all words.) 79 Investigational Device Exemption IDE 66 Fast Track Designation 65 Marketing Authorization Application 64 Marketing Authorization Application MAA 64 Biologics License Application 64 Orphan Drug Status 63 BLA submission 63 Pivotal Trial 63 Investigational 63 Special Protocol Assessment 63 Orphan Drug status 63 Pivotal Phase III 62 Biologics License Application BLA 62 IND submission 62 supplemental Biologics License Application 62 PROPEL trial 61 Phase III Clinical Trial 61 pseudobulbar affect PBA 61 Fast Track designation 61 Orphan Drug designation 60 Completes Enrollment 60 Marketing Authorization 60 Phase IIa clinical trials 60 confirmatory Phase 3 59 prGCD 59 orphan designation 59 sBLA 59 ATryn R 59 CORTOSS 58 Approvable Letter 58 ATryn ® 58 Pivotal Phase 58 Complete Response 58 FIRAZYR 58 Zelrix 58 NDA submission 58 Act PDUFA date 58 FDA Clearance 57 New Drug IND 57 Icatibant 57 alvimopan 57 Mutual Recognition Procedure 57 Orphan Drug Designation 57 MONOVISC 57 New Drug Application 57 investigational 57 Complete Response letter 57 confirmatory Phase III 57 ThermoDox ® 57 Qualifying Therapeutic Discovery 57 Genasense R 57 multicenter clinical 57 Virulizin R 57 Phase 2a clinical 57 Phase 2b clinical 57 FDA Approval 57 Phase III Trial 56 anticancer compound 56 Drug Application 56 TORISEL 56 pediatric exclusivity 56 Pirfenidone 56 Regulatory Approval 56 Ofatumumab 56 relapsed refractory multiple myeloma 56 Phase III clinical 56 Clinical Trial Results 56 FavId 56 pivotal Phase III 56 registrational trial 56 received CE Marking 56 NEUMUNE 56 sodium Injection 56 Receives FDA Clearance 56 Phase III pivotal 56 Genasense R oblimersen 55 sNDA 55 Phase 1b trial 55 Ceftobiprole 55 registrational 55 CE Marked 55 methylnaltrexone 55 Drug Eluting Stent 55 Clevudine 55 phase IIa 55 Exclusive License 55 refractory Hodgkin lymphoma 55 Receives CE 55 Phase 2a 55 pharmacologic stress agent 55 intravenous formulation 55 taliglucerase alfa 55 Phase IIa trial 55 Cinryze TM 55 Phase IIb clinical 55 Phase Ib 55 Amrubicin 54 Phase 1b clinical 54 Intermezzo R 54 NEBIDO 54 orphan medicinal product