Related by context. Frequent words. (Click for all words.) 56 BLA submission 52 Onsolis 51 TOCOSOL Paclitaxel 50 Complete Response 50 Replagal 50 ONSOLIS 49 Biologics License Application 49 NDA submission 49 Complete Response letter 49 ANDAs 49 Omnitrope 49 PhosLo 49 NUVIGIL 48 bazedoxifene 48 Rhucin 48 alogliptin 48 Bepreve 48 Exalgo 48 approvability 48 Rhucin ® 47 Factive 47 Icatibant 47 SFDA approval 47 Biologics License Application BLA 47 Viibryd 47 prGCD 46 USFDA 46 FDA 46 Abstral 46 GEM #S 46 KRYSTEXXA 46 Lumizyme 46 biogeneric 46 Neupro 46 Upsher Smith 46 Thyrogen 45 Synvisc One 45 Relistor 45 Hycamtin 45 Feraheme 45 pediatric exclusivity 45 GLUMETZA 45 Zelrix 45 FavId 45 supplemental Biologics License Application 45 Saphris 44 Vilazodone 44 CORTOSS 44 GRAS status 44 Stelara 44 Krystexxa 44 Increlex 44 FENTORA 44 Thecompany 44 CHMP opinion 44 PROPEL trial 44 Extavia 43 bioequivalence 43 Treximet 43 Cubicin 43 alvimopan 43 Osteocel 43 BioMimetic 43 biosimilar 43 Xyotax 43 Mitigation Strategy REMS 43 Vimovo 43 Fosrenol 42 Indiplon 42 Marketing Authorization 42 Fanapt 42 Amevive 42 Testim 42 Avastin bevacizumab 42 Ampligen 42 CHMP 42 LeMaitre Vascular 42 Myobloc 42 confirmatory Phase 3 42 Folotyn 42 Promacta 41 motavizumab 41 Juvista 41 Cimzia 41 Trexima 41 Clolar 41 BioDelivery Sciences 41 Xanodyne 41 Recothrom 41 clinical trials 41 Mylotarg 41 Tygacil 41 investigational 41 Horizant 41 Afrezza 40 phase IIa 40 Citizen Petition 40 Complete Response Letter 40 GSK 40 PDUFA date 40 Bydureon