Related by context. Frequent words. (Click for all words.) 68 supplemental Biologics License Application 61 Soliris TM eculizumab 60 Application BLA 60 Biologics License Application BLA 59 IND Investigational New 59 Biologics License Application 59 Marketing Authorization Application 58 sBLA 57 ZEGERID Capsules 57 Rhucin ® 56 registrational 56 Panzem R 56 FDA Accepts 56 Marketing Authorization Application MAA 56 BLA submission 56 Orphan Drug status 56 Pivotal Phase III 56 Golimumab 56 Entereg R 56 Priority Review 56 Complete Response 56 Icatibant 56 Loramyc R 55 SILENOR TM 55 BENLYSTA 55 ATryn ® 55 PMA submission 55 Exelbine 55 FavId 55 Investigational Device Exemption 55 Paragraph IV 55 CHMP recommendation 55 faropenem 55 submitted Biologics License 55 Pirfenidone 55 Application MAA 55 Telavancin 54 INDs 54 EEO Public 54 application sNDA 54 MONOVISC 54 summary judgment de novo 54 OTHER DAYS 54 Vilazodone 54 ATryn R 54 Phenoptin 54 candidate brentuximab vedotin 54 Hepatitis C HCV 54 refractory chronic lymphocytic 54 TranSwitch indebtedness 54 FDA Orphan Drug 54 MOZOBIL 54 BEMA TM Fentanyl 53 Kiadis Pharma 53 Shigamabs ® 53 submitted Marketing Authorization 53 ROTATEQ 53 exemption IDE 53 Phase Ib II 53 sNDA 53 REUTERS Arnd Wiegmann 53 Alzhemed TM 53 XM Radio Investor Relations 53 Fast Track Designation 53 pediatric exclusivity 53 By DON CUDDY 53 Pharming website http:/www.pharming.com 53 alvimopan 53 Fibrillex TM 53 WILEX 53 IND submission 53 M Enoxaparin 52 www.Navistar.com newsroom 52 Cladribine Tablets 52 Orphan Drug designation 52 Rhucin 52 dalbavancin 52 BY BEN POPKEN 52 Rotarix R 52 Toctino ® 52 Cancellation fees 52 subcutaneous formulation 52 phase IIa clinical 52 Restanza 52 PREOS 52 Alnylam maintains 52 By Laurelle Gilbert 52 orphan designation 52 ANDA approvals 52 Æterna Zentaris 52 TRISENOX 52 SCHWARZ PHARMA 52 BY ADRIAN NEMES 52 Clinical Trial Application 52 MHLW 52 Augment Bone Graft 52 NEBIDO 52 refractory Hodgkin lymphoma 52 REUTERS Yuriko Nakao 52 confirmatory Phase 3 52 AZX#