Related by context. Frequent words. (Click for all words.) 62 Biologics License Application 61 IND Investigational New 61 FDA Accepts 61 supplemental Biologics License Application 60 FDA Complete Response 60 Biologics License Application BLA 59 FDA approvable letter 59 Investigational Device Exemption 59 Market Approval PMA 59 Complete Response 59 PMA submission 59 Marketing Authorization Application 58 Act PDUFA date 58 Application MAA 58 Fast Track Designation 58 application sNDA 58 Drug Submission 58 BLA submission 58 Panzem R 58 Pivotal Phase III 57 IND submission 57 refractory chronic lymphocytic 57 sBLA 57 Initiates Phase II 57 Complete Response letter 57 Receives Orphan Drug Designation 57 Drug Application 57 MAA submission 57 Clinical Trial Application 56 Approvable Letter 56 Presents Positive 56 Entereg R 56 Application BLA 56 TranSwitch indebtedness 55 Soliris TM eculizumab 55 Phase III Clinical Trial 55 pediatric exclusivity 55 ZEGERID Capsules 55 Humanitarian Device Exemption 55 Meets Primary Endpoint 55 Roflumilast 55 By RohitSharma TennisEarth.com 55 SILENOR ™ 55 Marketing Authorization Application MAA 55 Arthritis Drug 54 BioGlue R 54 Junovan 54 Drug Shows Promise 54 QNEXA 54 Zytiga 54 NEBIDO R 54 R sorafenib tablets 54 optical biosensors 54 Orphan Drug Status 54 Complete Response Letter CRL 54 submitted Biologics License 54 Complete Response Letter 54 Risk Factors contained therein 54 Completes Enrollment 54 Specifications pricing 54 Exelbine 54 sNDA 54 exocrine pancreatic insufficiency 54 Ticagrelor 54 Orphan Drug status 54 PLK1 SNALP 54 Recombinant Human 53 CHMP recommendation 53 NEBIDO 53 Prestara 53 IMC #B 53 Initiate Phase 53 By KushalSharma TennisEarth.com 53 Citizen Petition 53 nonclinical studies 53 Surgical Adhesive 53 approvable letters 53 Pharming website http:/www.pharming.com 53 Clinical Trials Update 53 Patient Enrollment 53 liprotamase 53 Scientific Advice 53 Generic Version 53 PREOS 53 ANDA containing 53 gets USFDA nod 52 NDA submission 52 editor letters@smdailyjournal.com 52 New Drug Application 52 ThermoDox R 52 eprodisate KIACTA TM 52 Pirfenidone 52 Investigational 52 Extended Release 52 By RICK CASEY 52 AzaSite Plus 52 Company Nasdaq PRGO 52 Drug Candidate 52 Nebido 52 alogliptin 52 exemption IDE