Related by context. Frequent words. (Click for all words.) 77 Complete Response letter 72 approvable letter 71 Approvable Letter 71 Complete Response 71 Complete Response Letter 67 PDUFA date 66 sNDA 65 Biologics License Application 65 Act PDUFA date 64 Marketing Authorization Application 64 Biologics License Application BLA 63 sBLA 63 Marketing Authorization Application MAA 63 BioDelivery Sciences 62 Promacta 62 alogliptin 62 bazedoxifene 61 Vilazodone 61 Citizen Petition 61 Trexima 61 CHMP opinion 61 alvimopan 61 NDA submission 60 Krystexxa 60 orphan designation 60 New Drug Application 60 PREOS 60 Exalgo 60 CHMP 59 BYDUREON 59 iloperidone 59 eltrombopag 59 Jevtana 59 PROMACTA 59 European Medicines Evaluation 59 diabetic neuropathic pain 59 Afrezza 59 methylnaltrexone 59 Drug Application 59 Marketing Authorization 59 Indiplon 58 QRxPharma 58 pediatric exclusivity 58 Staff Determination Letter 58 Torisel 58 Bydureon 58 bifeprunox 58 Phase IIa trial 58 See BioWorld Today 58 Rhucin 58 BENLYSTA 57 Horizant 57 Icatibant 57 Phenoptin 57 Fast Track designation 57 JZP 6 57 Zelrix 57 Stelara 57 Oracea 57 aztreonam lysine 57 Orphan Drug designation 57 Relistor 57 Paragraph IV certification 57 Frova 56 Treximet 56 PRX # 56 Replagal 56 ATryn R 56 Orphan Drug status 56 Sancuso 56 vilazodone 56 Treanda 56 Caduet 56 Acetavance 56 confirmatory Phase III 56 SILENOR TM 56 APF# 56 teduglutide 56 Palatin Technologies Inc. 56 Staff Deficiency Letter 56 Strativa 56 CoFactor 56 indiplon 56 Abstral 56 LIALDA 56 Taxotere ® 56 Opana ER 56 Vasovist 56 chronic angina 56 phase IIa 56 Omnitrope 56 Flutiform 56 Zenvia 55 Santhera 55 Rhucin ® 55 Antegren 55 Phase IIa clinical trials 55 NASDAQ BPAX 55 Galvus 55 Arzerra 55 SFDA approval