Related by context. Frequent words. (Click for all words.) 78 Complete Response 77 FDA approvable letter 75 Approvable Letter 74 FDA Accepts 74 Complete Response letter 72 Pivotal Phase III 71 Phase III Clinical Trial 71 Complete Response Letter 69 Patient Enrollment 69 Pivotal Trial 68 Marketing Authorization Application 68 FDA Clearance 68 Clinical Trial Results 68 Drug Candidate 68 Biologics License Application 68 BioDelivery Sciences 67 Pulmonary Arterial Hypertension 67 Citizen Petition 67 Generic Version 67 Phase III Trial 67 Presents Positive 66 Drug Application 66 Positive Opinion 66 Extended Release 66 Completes Enrollment 66 Pirfenidone 66 Biologics License Application BLA 66 BLA submission 65 Full Prescribing Information 65 Telavancin 65 pseudobulbar affect PBA 65 Panzem R 65 FDA Clears 65 Investigational Device Exemption 65 Fast Track Designation 65 Metastatic Melanoma 64 supplemental Biologics License Application 64 application sNDA 64 PROMACTA 64 Marketing Authorization Application MAA 64 FDA Approval 64 alvimopan 64 NASDAQ SHPGY 64 approvable letter 64 Orphan Drug Status 64 Pivotal Phase 63 sBLA 63 dalbavancin 63 sNDA 63 Cethromycin 63 orphan designation 63 Preclinical Data 63 Monotherapy 63 NEBIDO 63 Traficet EN 63 Marketing Authorization 63 RNAi Therapeutics 63 Eltrombopag 63 Warning Letter 63 Metastatic Colorectal Cancer 63 FIRAZYR 63 Irinotecan 63 Icatibant 63 Overactive Bladder 63 Lenalidomide 63 Octreotide 63 Phenoptin 63 Act PDUFA date 63 elotuzumab 62 REVLIMID R 62 Dasatinib 62 Neurodex 62 liposomal formulation 62 Vilazodone 62 ATL# [001] 62 FDA Orphan Drug 62 Investigational Device Exemption IDE 62 Clevudine 62 QNEXA 62 Immunogenicity 62 Extended Release Tablets 62 methylnaltrexone 62 Orphan Drug status 62 ISPH 62 PMA submission 62 IND submission 62 IPLEX 62 Bicifadine 62 DOXIL 62 NOXAFIL 62 Natalizumab 62 Solid Tumors 62 Anika Therapeutics 62 Vandetanib 62 PEG SN# 61 Epratuzumab 61 FDA Advisory Panel 61 anticancer compound 61 submitted Biologics License 61 New Drug Application 61 diabetic neuropathic pain