Related by context. Frequent words. (Click for all words.) 53 Hycamtin 53 Cladribine 53 BLA submission 53 randomized controlled clinical trials 53 Xgeva 53 ustekinumab 52 liprotamase 52 postmarketing 52 Neurodex 52 Stelara 51 PREOS 51 FDA 51 MIRCERA 51 postmarket 51 placebo controlled trials 50 clinical trials 50 biogeneric 50 pediatric exclusivity 50 bioequivalence 50 NOXAFIL 50 Torisel 49 preapproval 49 approvability 49 CDER 49 Mylotarg 49 PDUFA 49 FDA reviewers 49 surrogate endpoints 48 alvimopan 48 ATryn ® 48 randomized clinical trials 48 INTELENCE 48 Xyotax 48 eltrombopag 48 Alzhemed 48 Saphris 48 bazedoxifene 48 Genentech Avastin 48 Allovectin 7 R 48 Anthim 48 Jevtana 48 Clolar 48 clinical endpoints 48 omalizumab 47 Advexin 47 Avastin bevacizumab 47 therapeutic regimens 47 Replagal 47 BENLYSTA 47 Zelrix 47 valopicitabine 47 supplemental Biologics License Application 47 tamoxifen therapy 47 Phase IIa clinical trials 47 Sensipar 47 temsirolimus 47 Board DSMB 47 PROMACTA 47 European Medicines Evaluation 47 NEBIDO 47 teriparatide 47 Research CDER 47 Promacta 47 placebo controlled studies 47 Gilenia 47 PhosLo 47 PROPEL trial 46 Asentar 46 Vilazodone 46 Biologics License Application BLA 46 Neuradiab 46 Amevive 46 TOCOSOL Paclitaxel 46 Diamyd ® 46 JANUMET 46 Increlex 46 Probuphine 46 IRESSA 46 decitabine 46 NSABP 46 ProAmatine 46 Pirfenidone 46 alogliptin 46 FOSRENOL R 46 Viibryd 46 phosphate binders 46 Extavia 46 antihypertensive agents 46 Trofile 46 NovoSeven 46 PegIntron 46 Bydureon 46 Clinical trials 46 Krystexxa 46 Marketing Authorization Application 46 ATryn 46 TELCYTA 46 Thyrogen 45 Factive 45 Camptosar 45 Complete Response