Related by context. Frequent words. (Click for all words.) 73 supplemental Biologics License Application 72 Biologics License Application BLA 72 Biologics License Application 69 sBLA 69 Marketing Authorization Application 68 BLA submission 67 application sNDA 67 Omigard 66 Marketing Authorization Application MAA 66 FDA Accepts 65 Investigational Device Exemption 65 Complete Response 64 FDA approvable letter 63 sNDA 63 Rotarix R 63 Pivotal Phase III 63 ROTATEQ 63 Zelrix 63 PREOS 63 Market Approval PMA 63 Icatibant 63 Veronate 63 BENLYSTA 63 Marketing Authorization 63 Panzem R 63 NEBIDO 63 Clinical Trial Application 63 Solzira 62 Restanza 62 BEMA Fentanyl 62 QNEXA 62 IND submission 62 registrational 62 OFIRMEV 62 New Drug Application 62 MONOVISC 62 Act PDUFA date 62 Orphan Drug designation 62 Phase III Clinical Trial 62 Investigational Device Exemption IDE 62 Clevudine 62 Zalbin 62 alvimopan 61 dalbavancin 61 Orphan Drug status 61 Exelbine 61 Hepatitis C HCV 61 Telavancin 61 Orphan Drug Status 61 R sorafenib tablets 61 Plenaxis R 61 FIRAZYR 61 Fast Track Designation 61 ATryn ® 61 Nasdaq VRTX 61 Jevtana 61 Rhucin ® 61 NDA submission 61 Scientific Advice 61 orphan designation 61 liprotamase 60 ZALBIN 60 ponatinib 60 Complete Response letter 60 Phenoptin 60 Acetavance 60 liposomal formulation 60 ATryn R 60 bazedoxifene 60 Anthim 60 European Medicines Evaluation 60 submitted Marketing Authorization 59 Exalgo 59 Oncologic Drugs Advisory 59 celgosivir 59 orphan medicinal product 59 Onsolis 59 apaziquone 59 KRN# 59 INDs 59 Pivotal Phase 59 maribavir 59 pediatric exclusivity 59 Urocidin 59 Pennsaid R 59 Vilazodone 59 Mutual Recognition Procedure 59 Marqibo 59 Pirfenidone 59 Presents Positive 59 rhThrombin 59 JZP 6 59 methylnaltrexone 59 TOCOSOL Paclitaxel 58 confirmatory Phase III 58 ridaforolimus 58 sodium Injection 58 Pivotal Trial 58 Amrubicin 58 BioDelivery Sciences 58 elotuzumab