Related by context. Frequent words. (Click for all words.) 67 Drug Application 65 Biologics License Application 65 sNDA 64 Marketing Authorization Application MAA 64 Biologics License Application BLA 63 Investigational 63 Marketing Authorization Application 62 Complete Response 62 Pivotal Phase III 62 Act PDUFA date 60 Ceftobiprole 60 Marketing Authorization 60 sBLA 60 Investigational Device Exemption 60 Phase III Clinical Trial 60 supplemental Biologics License Application 59 Onsolis 59 Extended Release 59 FDA Clearance 59 Orphan Drug Status 59 IND submission 58 Swissmedic 58 Paladin Labs Inc. 58 Oral Solution 58 Extended Release Tablets 58 Pirfenidone 58 Citizen Petition 58 ONSOLIS 57 New Drug Application 57 Abstral 57 NEBIDO 57 Investigational Device Exemption IDE 57 Mutual Recognition Procedure 57 Therapeutic Products 57 THELIN 57 BLA submission 57 Paragraph IV 57 Complete Response letter 57 NOXAFIL 57 Pivotal Trial 57 Drug Candidate 57 Clevudine 56 FDA Clears 56 Icatibant 56 Approvable Letter 56 Priority Review 56 Fast Track Designation 56 Drug Administration USFDA 56 REPLAGAL 56 INDs 56 Fanapt 56 orphan designation 56 BioDelivery Sciences 56 Tygacil 56 cervical cancer vaccine Cervarix 55 VIBATIV 55 FDA Approval 55 European Medicines Evaluation 55 Factive 55 PREOS 55 Gestiva 55 Full Prescribing Information 55 Completes Enrollment 55 BEMA Fentanyl 55 Final Prospectus 55 alvimopan 55 methylnaltrexone 54 prGCD 54 FOSRENOL 54 Paladin Labs 54 NUVIGIL 54 PDUFA date 54 Torisel 54 FIRAZYR 54 ELND# 54 Orphan Drug designation 54 ANDAs 54 silodosin 54 Abbreviated New 54 Upsher Smith 54 Horizant 54 CE Marked 54 Exalgo 54 Relistor 54 Cimzia ® 54 Loramyc ® 54 alogliptin 54 Hydrochloride 54 Topiramate 54 USFDA 54 Clinical Trial Results 54 Influenza Vaccine 54 SFDA approval 54 ATryn ® 54 ANDA 54 TYKERB 54 Toctino R 54 Pivotal Phase 53 GlaxoSmithKline plc GSK 53 PhosLo 53 Fast Track designation