Related by context. Frequent words. (Click for all words.) 60 submitted Marketing Authorization 59 Alitretinoin 59 Orphan Drug status 57 Orphan Drug designation 57 supplemental Biologics License Application 56 orphan designation 56 granted orphan 56 submitted Biologics License 56 Application MAA 56 refractory chronic lymphocytic 56 Priority Review 55 ATryn ® 55 alogliptin 55 rheumatoid arthritis psoriasis 55 SEROQUEL XR 55 Argatroban 55 granted Orphan Drug 54 Application BLA 54 Act PDUFA date 54 Clevudine 54 alvimopan 54 ZALBIN 54 Fast Track Designation 54 Positive Opinion 54 Orphan Medicinal Product 54 DC Bead 53 Orphan Drug Status 53 CryoSeal FS System 53 Marketing Authorisation 53 Cladribine 53 orphan medicinal product 53 Orphan Drug Designation 53 ISTODAX 52 Biologics License Application 52 Marketing Authorization 52 ZOSTAVAX 52 Medicinal Products EMEA 52 granted Fast Track 52 optical biosensors 52 taliglucerase alfa 52 Combidex 52 Plenaxis R 52 calcineurin inhibitors 52 FIRAZYR 52 Swissmedic 52 INTERCEPT red 52 Marketing Authorization Application 52 ATryn R 51 Investigational Device Exemption 51 TRISENOX 51 Afresa 51 Zalbin 51 BYDUREON 51 biogeneric 51 THELIN 51 EPIX Pharmaceuticals 51 Icatibant 51 QAB# 50 Market Approval PMA 50 Lenalidomide 50 proteasome inhibitor 50 BENLYSTA 50 secondary hyperparathyroidism 50 Marketing Authorization Application MAA 50 human antithrombin 50 dalbavancin 50 bifeprunox 50 VALSTAR 50 Ceftobiprole 50 regulatory 49 Angiox 49 ONTAK 49 Cladribine Tablets 49 Abstral 49 Junovan 49 MEPACT 49 prGCD 49 Entereg R 49 Renvela 49 Exalgo 49 PTCRB 49 SAR# [004] 49 Drug Applications ANDAs 49 TRANSDUR Sufentanil 49 tumor lysis syndrome 49 BEXXAR 49 DMFs 49 Rhucin ® 49 ELAPRASE 49 sBLA 48 nosocomial pneumonia 48 REPLAGAL 48 Laquinimod 48 methylnaltrexone 48 Ixempra 48 Vasovist 48 Pennsaid R 48 CE Marked 48 Shire ADHD 48 Australian Therapeutic Goods 48 Mutual Recognition Procedure