Related by context. Frequent words. (Click for all words.) 66 submitted Biologics License 65 submitted Marketing Authorization 63 Investigational Device Exemption 63 Marketing Authorization Application 62 Orphan Drug Status 62 Biologics License Application 62 Mutual Recognition Procedure 61 Biologics License Application BLA 60 Marketing Authorization Application MAA 60 Marketing Authorization 60 supplemental Biologics License Application 59 Market Approval PMA 58 ATryn ® 58 ATryn R 58 Orphan Drug status 58 DC Bead 57 FDA Accepts 57 BEMA Fentanyl 56 Orphan Drug designation 56 Fast Track Designation 56 human antithrombin 56 Pivotal Phase III 56 BLA submission 56 Loramyc ® 56 Pivotal Trial 55 FIRAZYR 55 Investigational Device Exemption IDE 55 Phase III Clinical Trial 55 Act PDUFA date 55 Application 55 orphan designation 55 Vitaros 54 Pirfenidone 54 Clevudine 54 Humanitarian Device Exemption 54 Priority Review 54 sBLA 54 ZALBIN 54 Genasense R 54 NASDAQ Listing 54 Investigational 54 Patent Covering 54 CE Marked 53 application sNDA 53 CORTOSS 53 Clinical Trial Application 53 ROTATEQ 53 Scientific Advice 53 Augment Bone Graft 53 Phase IIB 53 Orphan Drug 53 Qualifying Therapeutic Discovery 53 Paragraph IV 53 Nasdaq VRTX 53 Diabetic Macular Edema 53 New Drug IND 53 PMA submission 53 Cladribine Tablets 53 Rhucin ® 53 THELIN 52 Patient Enrollment 52 Ceftobiprole 52 FDA Orphan Drug 52 Maraviroc 52 silodosin 52 Medicinal Products EMEA 52 Bone Graft 52 REPLAGAL 52 Shelf Registration Statement 52 Rotarix R 52 Plenaxis R 52 MONOVISC 52 Complete Response 52 Combidex 52 Hepatitis C HCV 52 Panzem R 52 Generic Version 52 Onsolis 52 Option Grants 52 SUMAVEL DosePro 52 Orphan Drug Designation 52 Orphan Medicinal Product 52 alvimopan 52 received CE Marking 52 Commercialization Agreement 52 SCHWARZ PHARMA 52 StemEx 52 Drug Application 52 prGCD 51 Neupro ® 51 Pennsaid R 51 Ofatumumab 51 European Medicines Evaluation 51 Nexavar ® 51 New Chemical Entities 51 Nimotuzumab 51 Telavancin 51 Securities andExchange Commission 51 ONSOLIS 51 IND submission 51 Notified Body