Related by context. Frequent words. (Click for all words.) 84 regulatory approvals 73 regulatory clearances 73 antitrust clearance 70 necessary regulatory approvals 67 approval 67 requisite regulatory approvals 66 approvals 61 customary regulatory approvals 60 shareholder approvals 58 governmental approvals 57 requisite approvals 56 applicable regulatory approvals 56 stockholder approval 56 Regulatory Approval 54 Orphan Drug designation 54 regulatory 53 customary closing conditions 52 customary closing 52 obtaining regulatory approvals 52 Biologics License Application 52 Approval 52 regulatory authorizations 51 Flutiform 50 Fast Track designation 50 definitive agreements 50 definitive documentation 49 Marketing Authorization Application 48 Marketing Authorization Application MAA 48 Hart Scott Rodino 47 commercialization 47 Vasovist 47 Orphan Drug Designation 47 Phase III clinical trials 46 Approvable Letter 46 sBLA 46 Renvela 46 Esbriet 46 New Drug Application 46 NovaDel 45 HSR Act 45 commercialize 45 Eligard 45 Cellegy 45 definitive agreement 45 k clearance 45 Antegren 45 Mozobil 45 clinical trials 44 acquisition 44 Antitrust Improvements Act 44 Bronchitol 44 authorizations 44 ambrisentan 44 orphan drug 44 NDA submission 44 approvable letter 43 orBec R 43 Biologics License Application BLA 43 Nycomed 43 requisite consents 43 authorization 43 private placement 43 pralatrexate 43 Investigational Device Exemption IDE 43 Neuromed 43 IND enabling 43 Opana ER 43 antitrust regulators 43 KRYSTEXXA 43 satisfactory due diligence 43 successfully commercialized 43 FDA Approval 43 divestiture 43 voclosporin 43 BENLYSTA 43 Consummation 42 Rhucin 42 Surfaxin 42 transaction 42 Zerenex 42 Approvals 42 Definitive Agreement 42 Completion 42 Phase III trials 42 Ceplene ® 42 Investigational 42 ATryn R 42 talactoferrin 42 Swiss drugmaker 42 DAVANAT ® 42 BYDUREON 42 commercialization milestones 42 L DOS# 42 clearance 41 ANDA 41 Pharmaxis 41 PDUFA date 41 Fodosine TM 41 Vicuron 41 antitrust immunity 41 Priority Review