Related by context. Frequent words. (Click for all words.) 60 Biologics License Application BLA 60 Marketing Authorization Application MAA 59 MONOVISC 57 Complete Response 57 Marketing Authorization Application 57 Biologics License Application 56 Investigational Device Exemption 56 Complete Response letter 56 Omigard 56 Zelrix 56 k clearance 55 New Drug Application 55 NEBIDO 55 Pivotal Phase III 55 IND submission 55 Ampligen R 54 IND 54 IMPAX Laboratories Inc. 54 BLA submission 54 Abbreviated New 54 Clevudine 54 Investigational Device Exemption IDE 54 New Drug IND 54 Paragraph IV 54 maribavir 54 VQD 54 ATryn ® 53 Mutual Recognition Procedure 53 ANDAs 53 Investigational 53 Orphan Drug Status 53 Nexavar ® 52 bazedoxifene 52 Drug Application 52 confirmatory Phase III 52 Icatibant 52 Marketing Authorization 52 Nimotuzumab 52 Staccato loxapine 52 REPLAGAL 52 silodosin 52 alogliptin 52 BMN 52 OTCQX RHHBY 52 phase IIa 52 Loramyc ® 52 IND enabling 52 Phase IIa trial 52 sBLA 52 USFDA 51 humanized monoclonal antibody 51 THELIN 51 PhosLo 51 vilazodone 51 milnacipran 51 Rhucin ® 51 Vilazodone 51 ATryn R 51 supplemental Biologics License Application 51 humanized anti 51 alvimopan 51 Nasdaq VRTX 51 CE Marked 51 Orphan Drug status 51 CE Marking 51 ecallantide 51 INDs 50 Phase III clinical 50 pivotal Phase III 50 VIMOVO 50 Tranzyme Pharma 50 HCV protease inhibitor 50 Paragraph IV certification 50 Fast Track designation 50 FDA Clearance 50 orphan designation 50 Act PDUFA date 50 CORTOSS 50 NDA submission 50 StaphVAX 50 Phase III Clinical Trial 50 Phenoptin 50 Oscient Pharmaceuticals Corporation 50 BioDelivery Sciences 50 FIRAZYR 50 Drug Administration FDA 50 Abstral 50 OLEPTRO TM 50 Pivotal Trial 50 Sosei 49 Phase IIa clinical trials 49 Phase 1b clinical 49 velaglucerase alfa 49 GEM #S 49 BEMA Fentanyl 49 Completes Enrollment 49 vitro diagnostic IVD 49 SFDA approval 49 Phase III clinical trials 49 Belinostat 49 Amrubicin