Related by context. Frequent words. (Click for all words.) 72 FDA Orphan Drug 68 Pivotal Phase III 68 FDA Accepts 67 Orphan Drug Status 66 Complete Response 66 Fast Track Designation 66 orphan designation 65 orphan medicinal product 65 Pivotal Phase 65 Phase III Clinical Trial 65 Orphan Drug status 64 Pirfenidone 64 Marketing Authorization 64 Positive Opinion 64 Patient Enrollment 64 Pivotal Trial 63 Orphan Drug Designation 63 Orphan Medicinal Product 63 Generic Version 63 Torisel 63 Act PDUFA date 63 Bortezomib 62 FDA Clearance 62 Orphan Drug designation 62 NOXAFIL 62 Marketing Authorization Application 62 Clinical Trial Results 62 Priority Review 62 supplemental Biologics License Application 62 Phase III Trial 62 Panzem R 62 Pulmonary Arterial Hypertension 61 Vandetanib 61 TYKERB 61 Biologics License Application BLA 61 Drug Candidate 61 Boxed Warning 61 Chronic Lymphocytic Leukemia 61 Ofatumumab 61 Monotherapy 61 Dasatinib 61 Lenalidomide 61 Metastatic Colorectal Cancer 61 Fidaxomicin 60 Alemtuzumab 60 Avastin bevacizumab 60 BioDelivery Sciences 60 Clevudine 60 Low Dose 60 Cethromycin 60 Pixantrone 60 TORISEL 60 Natalizumab 60 Bevacizumab 60 Icatibant 60 Epratuzumab 60 ISTODAX 60 alvimopan 60 Completes Enrollment 59 GSK# [001] 59 Fast Track designation 59 Biologics License Application 59 PROMACTA 59 REVLIMID lenalidomide 59 Traficet EN 59 Telavancin 59 prGCD 59 REVLIMID R 59 KRN# 59 Investigational Device Exemption 59 Orphan Drug 59 Preclinical Data 59 k Clearance 58 pediatric exclusivity 58 romiplostim 58 Medicinal Products EMEA 58 Neurodex 58 Cimzia R 58 Extended Release 58 Metastatic Melanoma 58 Vilazodone 58 pseudobulbar affect PBA 58 application sNDA 58 Solid Tumors 58 END FOOTNOTE 58 Anti TNF 58 Carfilzomib 58 tocilizumab 58 eltrombopag 58 Hycamtin 58 Phenoptin 58 Full Prescribing Information 58 Shelf Registration Statement 58 Enoxaparin 58 mTOR inhibitor 58 methylnaltrexone 58 sBLA 58 Prostate Cancer Treatment 58 Zelrix 58 Oral Solution 58 European Medicines Evaluation