Related by context. Frequent words. (Click for all words.) 59 Investigational Device Exemption 57 Orphan Drug Status 55 supplemental Biologics License Application 54 orphan designation 54 Fast Track Designation 54 Orphan Drug status 54 Orphan Drug designation 53 methylnaltrexone 53 alvimopan 53 TOCOSOL Paclitaxel 53 sBLA 52 Clolar 52 FavId 52 Treximet 52 Promacta 52 Icatibant 52 Pivotal Phase III 52 pediatric exclusivity 52 FIRAZYR 51 ATryn R 51 talactoferrin 51 Marketing Authorization Application 51 orphan medicinal product 51 prGCD 51 filgrastim 51 VIMOVO 51 Phase III Clinical Trial 51 alogliptin 50 Orphan Drug Designation 50 Fast Track designation 50 anti emetic 50 ATryn ® 50 Drug Application 50 Allovectin 7 R 50 PREOS 50 Seroquel XR 50 velaglucerase alfa 50 FDA Approval 50 Marketing Authorization Application MAA 49 SILENOR TM 49 antiemetic 49 Lamivudine 49 Exalgo 49 Cladribine Tablets 49 QAB# 49 Phenoptin 49 Phase IIa clinical trials 49 CHMP opinion 49 OFIRMEV 49 DAVANAT ® 49 BLA submission 49 Biologics License Application 49 valopicitabine 48 taliglucerase alfa 48 Rhucin ® 48 Investigational Device Exemption IDE 48 ambrisentan 48 HEPLISAV 48 Onsolis 47 pralatrexate 47 vernakalant oral 47 Xyotax 47 Yervoy 47 Indiplon 47 Priority Review 47 Relistor 47 Victrelis 47 Zerenex 47 Aloxi 47 Rhucin 47 BYDUREON 47 confirmatory Phase III 47 MOZOBIL 46 IND enabling 46 oral calcitonin 46 CORTOSS 46 ONSOLIS 46 BENLYSTA 46 Sensipar 46 Cinryze TM 46 Phase III Trial 46 Genentech Roche 46 Vimovo 46 Marketing Authorization 46 lubiprostone 46 Sancuso 46 Abstral 46 NDA submission 46 Zelrix 46 Orphan Medicinal Product 45 European Medicines Evaluation 45 SANCTURA R 45 Investigational 45 ComfortScan system 45 Final Approval 45 MONOVISC 45 Mutual Recognition Procedure 45 may visit adviserinfo.sec.gov 45 Biologics License Application BLA 45 Ceplene R 45 bifeprunox