Related by context. Frequent words. (Click for all words.) 63 BLA submission 61 Complete Response 60 Biologics License Application 60 FDA approvable letter 60 supplemental Biologics License Application 60 Marketing Authorization Application 60 www.emagazine.com/earthtalk/thisweek/ 59 Biologics License Application BLA 57 Symphony tCGM System 57 Exelbine 57 news@infibeam.com 57 Marketing Authorization Application MAA 56 AVAX 56 Complete Response letter 56 registrational 56 FDA Accepts 56 Restanza 56 bicifadine 56 IoGen 56 PMA submission 55 Application BLA 55 sBLA 55 OFIRMEV 55 TOCOSOL Paclitaxel 55 ASONEP 55 IMC #B 55 SinuNase 55 Pirfenidone 55 confirmatory Phase III 55 Urocidin 55 therapeutic monoclonal antibodies 54 rhThrombin 54 dalbavancin 54 Omigard 54 alvimopan 54 PREOS 54 NEBIDO 54 Patient Enrollment 54 Solzira 54 Zelrix 54 Combidex 54 refractory chronic lymphocytic 54 Clinical Trial Application 54 Photocure 54 maribavir 54 PROPEL trial 54 ISTODAX 54 SAR# [004] 54 Act PDUFA 54 pafuramidine 54 TOLAMBA 54 application sNDA 54 BrachySil 54 ATL# [001] 54 Panzem R 54 EFAPROXYN 54 Acetavance 54 Act PDUFA date 54 Phase IIa clinical trials 53 Application MAA 53 SILENOR TM 53 Poly ICR 53 ponatinib 53 voclosporin 53 MOZOBIL 53 Allovectin 7 R 53 apaziquone 53 NVA# 53 Phase III Clinical Trial 53 XPRESSTRADE policy 53 approvability 53 pharmacokinetic PK 53 vismodegib 53 phase Ib 53 bazedoxifene 53 Junovan 53 Pivotal Phase III 53 BEMA Fentanyl 53 Investigational Device Exemption 53 Zalbin 53 Rhucin 53 MacroChem 53 StaphVAX 53 PhosLo 52 elotuzumab 52 IND submission 52 Entereg R 52 Reader Comment Guidelines 52 FavId 52 vilazodone 52 BEMA TM Fentanyl 52 Diamyd ® 52 deforolimus 52 PROMACTA 52 liprotamase 52 enzastaurin 52 registrational trial 52 phase IIa clinical 52 pralatrexate 52 Vilazodone 52 tecarfarin