Related by context. Frequent words. (Click for all words.) 72 orphan medicinal product 72 Orphan Drug designation 72 Orphan Drug status 72 Orphan Medicinal Product 71 Orphan Drug Designation 70 orphan designation 70 Orphan Drug 69 Orphan Drug Status 68 FDA Accepts 68 Phase III Clinical Trial 68 Fast Track Designation 67 Positive Opinion 67 Priority Review 66 Pivotal Phase III 66 orphan drug 65 Pivotal Trial 64 granted Orphan Drug 64 Drug Candidate 64 FDA Clearance 64 Pivotal Phase 63 Metastatic Melanoma 63 Amrubicin 63 Clinical Trial Results 63 Elesclomol 63 Icatibant 63 Exclusive License 63 Completes Enrollment 63 Hycamtin 63 Marketing Authorization 63 ZALBIN 62 Phase III Trial 62 Cethrin 62 RNAi Therapeutics 62 Phenoptin 62 Pirfenidone 62 Alemtuzumab 62 Ofatumumab 61 Bevacizumab 61 Gaucher Disease 61 Monoclonal Antibody 61 Torisel 61 Cethromycin 61 REVLIMID R 61 Complete Response 61 Carfilzomib 61 NEUMUNE 60 Fast Track designation 60 Perifosine 60 k Clearance 60 Nexavar ® 60 refractory Hodgkin lymphoma 60 methylnaltrexone 60 Small Molecule 60 Genasense R 60 ATryn ® 60 ATL# [001] 60 Zolinza 60 Onalta 59 Combination Therapy 59 pediatric exclusivity 59 Investigational Device Exemption 59 Pixantrone 59 granted orphan 59 Marketing Authorization Application 59 Lenalidomide 59 PROMACTA 59 Fidaxomicin 59 Orphan Drug Act 59 Full Prescribing Information 59 LymphoStat B 59 pseudobulbar affect PBA 59 Boxed Warning 59 registrational trial 59 Voreloxin 59 Regulatory Approval 59 alvimopan 59 Restanza 59 Drug Eluting Stent 59 FDA Approval 58 supplemental Biologics License Application 58 Nimotuzumab 58 Tygacil 58 MEK inhibitor 58 Initiates Phase 58 Telavancin 58 Everolimus 58 Clavis Pharma 58 KNS # 58 ThermoDox ® 58 Avastin bevacizumab 58 maribavir 58 Hepatitis C Virus HCV 58 ONSOLIS 58 Anthim 58 eltrombopag 58 FDA Clears 58 TORISEL 58 Leukine 58 mTOR inhibitor 58 thymalfasin 58 Act PDUFA date