Related by context. Frequent words. (Click for all words.) 67 Complete Response letter 67 Complete Response 65 Biologics License Application BLA 64 Biologics License Application 64 BLA submission 64 Complete Response Letter 63 Act PDUFA date 63 sBLA 61 SILENOR TM 61 alogliptin 61 sNDA 61 Approvable Letter 60 Board DSMB 60 L MTP PE 60 Marketing Authorization Application 60 alvimopan 59 approvability 59 NDA submission 59 Acetavance 58 confirmatory Phase III 58 New Drug Application 58 PREOS 58 Phenoptin 58 PDUFA date 57 OFIRMEV 57 BYDUREON 57 resubmission 57 Marketing Authorization Application MAA 56 PROMACTA 56 Metabolic Drugs Advisory 56 confirmatory Phase 3 56 Lumizyme 56 Krystexxa 56 Mitigation Strategy REMS 56 Intermezzo ® 56 Indiplon 55 Jevtana 55 TOCOSOL Paclitaxel 55 approvable letter 55 iloperidone 55 Intermezzo R 55 Icatibant 55 Horizant 55 bifeprunox 55 BENLYSTA 55 pegloticase 54 phase IIb 54 PROPEL trial 54 taliglucerase alfa 54 Zelrix 54 teduglutide 54 Marqibo 54 Phase IIa clinical trials 54 Phase 1b trial 54 JZP 6 54 bazedoxifene 54 indiplon 54 Trexima 54 Exalgo 54 pralatrexate 54 Onsolis 54 Phase IIa trial 54 phase 2a 54 Phase IIb clinical 53 PhosLo 53 Drug Application 53 FUSILEV 53 Citizen Petition 53 Phase 2a clinical 53 Phase 2a trial 53 RHUCIN 53 NUVIGIL 53 denufosol 53 Nasdaq VRTX 53 TELCYTA 53 Phase 1a 53 Act PDUFA 53 LIALDA 53 KRYSTEXXA 53 CoFactor 53 Phase 1b clinical 53 Investigational Device Exemption IDE 53 Promacta 53 Fast Track Designation 53 Phase 2b clinical 53 registrational 53 TYKERB 53 Corautus 53 Vilazodone 53 ferumoxytol 53 Phase Ia 53 Empatic 53 Full Prescribing Information 53 tanespimycin 53 CHMP 53 Phase 2b study 53 Entereg 53 Fampridine SR 53 ATryn R 52 Phase IIa clinical 52 Sparlon