Related by context. Frequent words. (Click for all words.) 71 PDUFA 67 Act PDUFA 65 Prescription Drug User Fee 60 NDA submission 59 sNDA 59 sBLA 58 Marketing Authorization Application 58 Complete Response Letter 57 approvable letter 57 Fast Track designation 57 BENLYSTA 56 pralatrexate 56 Zerenex 55 Priority Review 55 Marketing Authorization Application MAA 55 New Drug Application 54 Orexo 54 resubmission 54 See BioWorld Today 54 INCB# [002] 54 Mozobil 54 Bydureon 54 Marqibo 54 Feraheme 54 Orphan Drug Designation 53 vilazodone 53 CHMP 53 ambrisentan 53 Kuvan 53 BDSI 53 L MTP PE 53 Phase 2b trial 53 ANDAs 53 phase IIb 53 mipomersen 52 clofarabine 52 orphan drug 52 Trexima 52 Santhera 52 Lumizyme 52 daclizumab 52 Phase III trials 52 Clolar 52 confirmatory Phase 3 52 Qutenza 52 Entereg 52 Treximet 51 ADVEXIN 51 Pennsaid 51 Rhucin 51 Encysive 51 LibiGel 51 Keryx Biopharmaceuticals 51 Sucampo 51 MGCD# [001] 51 Ceplene 51 DAVANAT ® 51 Avanir 51 milnacipran 51 Drug Application 51 Drug Administration FDA 50 vandetanib 50 APF# 50 AMR# 50 Bronchitol 50 indiplon 50 Neuromed 50 investigational compound 50 FDA 50 Dyloject 50 Poniard 50 IMGN# 50 Jerini 50 Aspreva 50 satraplatin 50 Phase IIa trial 50 Dacogen 50 linaclotide 50 NovaDel 50 oncology indications 49 Contrave 49 Antegren 49 Galvus 49 Oral Suspension 49 Repros 49 voreloxin 49 DAVANAT R 49 CORLUX 49 Cimzia 49 Allos 49 Intermezzo R 49 patent expiry 49 ALKS 49 asenapine 49 KRYSTEXXA 49 Onglyza 49 Satraplatin 49 Phase IIb trial 49 Ranexa 49 AEterna Zentaris 49 REMS