Related by context. Frequent words. (Click for all words.) 74 Biologics License Application BLA 74 FDA Accepts 72 Biologics License Application 71 supplemental Biologics License Application 70 Marketing Authorization Application 69 Pivotal Phase III 69 Marketing Authorization Application MAA 68 Complete Response 67 Phase III Clinical Trial 66 New Drug Application 65 sBLA 64 Marketing Authorization 63 Pivotal Trial 63 Drug Application 63 Phase III Trial 63 Drug Candidate 62 prGCD 62 Pivotal Phase 62 Positive Opinion 62 FDA approvable letter 62 Extended Release Tablets 61 sNDA 61 Act PDUFA date 61 Citizen Petition 61 Investigational Device Exemption 61 Extended Release 60 Investigational 60 BLA submission 60 NDA submission 60 Telavancin 60 Pirfenidone 60 Zalbin 59 FDA Approval 59 Orphan Drug Status 59 INDs 59 Mutual Recognition Procedure 59 Clinical Trial Results 59 Completes Enrollment 58 BioDelivery Sciences 58 Priority Review 58 Investigational Device Exemption IDE 58 Jevtana 58 FDA Clearance 58 Fast Track Designation 58 Cholesterol Drug 58 Market Approval PMA 58 Vitaros 57 Paragraph IV 57 Horizant 57 European Medicines Evaluation 57 Icatibant 57 IND submission 57 Ceftobiprole 57 Oral Solution 57 Phenoptin 57 Neurodex 57 Initiates Phase 57 ANDAs 57 Full Prescribing Information 57 taliglucerase alfa 57 Fast Track designation 57 Omigard 57 Nexavar ® 57 Orphan Drug Designation 57 IND 57 Cethromycin 57 FDA Approves 57 Exalgo 56 confirmatory Phase 3 56 Scientific Advice 56 Clevudine 56 USFDA approval 56 JZP 6 56 ATryn R 56 Ofatumumab 56 alvimopan 56 NEBIDO 56 Zelrix 56 Rhucin ® 56 NUVIGIL 56 Advexin 56 Final Approval 56 Exelbine 56 EPIX Pharmaceuticals 56 Onsolis 56 pivotal Phase III 56 FDA Clears 56 ZALBIN 56 RNAi Therapeutics 55 alogliptin 55 MOZOBIL 55 Drug Administration USFDA 55 StaphVAX 55 PREOS 55 Phase III clinical 55 Orphan Drug designation 55 Augment Bone Graft 55 Cladribine 55 MONOVISC 55 Shelf Registration Statement 55 orphan designation