Related by context. Frequent words. (Click for all words.) 81 Orphan Drug Status 78 Orphan Drug status 78 Fast Track designation 74 Orphan Drug designation 72 Orphan Medicinal Product 72 Orphan Drug Designation 71 orphan designation 67 Priority Review 66 orphan medicinal product 66 Pivotal Trial 66 Investigational Device Exemption 65 Orphan Drug 64 Drug Candidate 64 Marketing Authorization Application 64 Pivotal Phase III 64 Phase III Trial 63 supplemental Biologics License Application 63 FDA Clearance 62 Completes Enrollment 62 TORISEL 62 pseudobulbar affect PBA 62 Marketing Authorization 62 PROMACTA 62 Ofatumumab 62 ThermoDox ® 62 Pivotal Phase 62 Everolimus 62 REVLIMID R 62 methylnaltrexone 61 Pixantrone 61 Pirfenidone 61 Monotherapy 61 orphan drug 61 k Clearance 61 Icatibant 61 Complete Response 61 Torisel 61 FDA Approval 60 Alemtuzumab 60 Irinotecan 60 Cinryze TM 60 Lenalidomide 60 SUTENT 60 ATryn R 60 sBLA 60 Approvable Letter 60 granted orphan 59 Genasense R 59 Bevacizumab 59 Investigational Device Exemption IDE 59 Combination Therapy 59 Clinical Trial Results 59 Hepatitis C Virus HCV 59 Amrubicin 59 Nimotuzumab 59 Marketing Authorization Application MAA 59 Initiates Phase 59 Azedra 59 VIBATIV 58 Patients Treated 58 granted Orphan Drug 58 NEUMUNE 58 Nexavar ® 58 Biologics License Application 58 alvimopan 58 pediatric exclusivity 58 Perifosine 58 pancreatic insufficiency 58 Act PDUFA date 58 Rifaximin 58 FIRAZYR 58 TYKERB 58 TREANDA 58 injectable formulation 57 Fidaxomicin 57 NOXAFIL 57 REVLIMID ® 57 ONSOLIS 57 lymphoma CTCL 57 Clolar 57 Chronic Hepatitis C 57 prGCD 57 FDA Clears 57 gastrointestinal stromal tumors 57 FDA Approves 57 Voreloxin 57 diabetic neuropathic pain 57 taliglucerase alfa 57 XGEVA 57 BLA submission 57 European Medicines Evaluation 57 Allovectin 7 R 57 eltrombopag 57 Low Dose 56 oncology indications 56 Amigal 56 MOZOBIL 56 Zelrix 56 Receives FDA Clearance 56 temsirolimus 56 Jevtana