Related by context. All words. (Click for frequent words.) 74 BLA filing 73 NDA submission 73 MAA submission 73 sNDA submission 71 Biologics License Application BLA 70 Biologics License Application 70 registrational 69 IND submission 69 Marketing Authorization Application 69 oral ridaforolimus 69 PMA submission 68 Biologic License Application BLA 68 Phase IIa trials 67 Dacogen injection 67 Phase Ib study 67 Saforis 67 Omigard 67 RIGScan CR 67 NEBIDO 67 PREOS R 67 Phase IIa trial 66 ENRICH trial 66 Azedra 66 PREOS 66 FDA approvable letter 66 Phase IIa clinical trials 66 Phase IIb clinical trials 66 Orathecin 66 CIP TRAMADOL ER 66 Exelbine 66 GLP toxicology studies 66 registrational trial 66 FDA Approvable Letter 65 Phase Ib 65 Virulizin R 65 ZEGERID Capsules 65 sBLA 65 IMA# 65 L MTP PE 65 APF# NDA 65 alvimopan 65 elotuzumab 65 GAMMAGARD 65 octreotide implant 65 Icatibant 65 Complete Response 65 UVIDEM 65 phase IIb clinical 65 Civacir 65 Phase 2a clinical trials 65 torezolid phosphate 65 Phase IIIb clinical 65 FDA Investigational Device 65 confirmatory Phase 3 65 Phase 2a trial 65 Phenoptin 65 SUCCEED trial 65 phase IIb trial 65 confirmatory Phase III 65 FOLOTYN ® 65 PLK1 SNALP 65 GALNS 65 UPLYSO 65 NDA resubmission 64 Aurexis 64 ruxolitinib 64 Junovan 64 AzaSite Plus 64 YONDELIS 64 trastuzumab DM1 T DM1 64 Premarket Approval PMA 64 maribavir 64 PROPEL trial 64 Phase 2b trial 64 FavId 64 placebo controlled Phase 64 Neuradiab 64 Intermezzo ® NDA 64 Marketing Authorisation Application 64 CHMP recommendation 64 application sNDA 64 Biological License Application 64 pivotal bioequivalence 64 Plicera 64 SNT MC# 64 COMFORT II 64 IND Investigational New 64 indiplon capsules 64 ponatinib 64 Fodosine 64 LUMINATE 64 MONOVISC 64 SILENOR TM 64 DR Cysteamine 64 PDE4 inhibitor 64 Phase IIB 63 nonclinical studies 63 PRECISE trial 63 T Pred 63 TOLAMBA 63 Phase III clinical 63 CRMD# 63 phase IIa clinical 63 ATryn R 63 Allovectin 7 R 63 Investigational Device Exemption 63 Diamyd ® 63 SPARLON 63 HepaGam B 63 CLIRS trial 63 peginesatide 63 BRILINTA 63 lorcaserin Phase 63 APF# 63 MGN# 63 dirucotide 63 Azedra ™ 63 Marketing Authorization Application MAA 63 MAXY alpha 63 REPLAGAL 63 tramiprosate ALZHEMED TM 63 NADiA ProsVue 63 Amigal 63 OvaRex ® MAb 63 Zelrix 63 Amrubicin 63 Phase lll 63 HCV protease inhibitor 63 Certican 63 EndoTAG TM -1 63 Cellegesic 63 Augment Injectable 63 LibiGel NDA 63 Glybera R 63 Onco TCS 63 PIX# trial 63 PANVAC VF 63 faropenem 63 talactoferrin 63 midstage studies 63 Phase IIb III 63 Pirfenidone 63 ATPace TM 63 GATTEX TM 63 Somatuline R Autogel R 63 Phase #b/#a 63 Fibrillex TM 63 BrachySil 63 Marqibo 63 MyVax R 63 MOZOBIL 63 Premarket Approval Application 63 eprodisate KIACTA TM 62 Rhucin ® 62 rALLy trial 62 PROVENGE sipuleucel T 62 Urocidin 62 IL# PE#QQR 62 Phase Ib II 62 lorcaserin NDA 62 Archexin 62 #D#C# 62 oxymorphone ER 62 CCX# 62 StemEx R 62 ATL# [001] 62 Firazyr 62 Voraxaze 62 teduglutide 62 Soliris eculizumab 62 Allovectin 7 62 sNDA 62 CIP ISOTRETINOIN 62 Phase III clinical trials 62 Luveniq 62 Trizytek 62 Phase 1b trial 62 Phase 1a clinical 62 Telatinib 62 rALLy clinical trial 62 FAME Study 62 Phase #b/#a clinical 62 Aryplase 62 pegloticase 62 BEXXAR 62 Shigamabs ® 62 tolevamer 62 pivotal Phase III 62 velafermin belinostat 62 Solazed 62 nalbuphine ER 62 orBec 62 acyclovir Lauriad R 62 Investigational Device Exemption IDE 62 New Drug Application 62 Evoltra 62 ONCONASE R 62 EFAPROXYN 62 Virulizin ® 62 ELACYT 62 Allovectin 7 r 62 EOquin TM 62 pradefovir 62 CoFactor 62 phase IIb 62 L BLP# 62 orphan designation 62 INCB# [001] 62 vilazodone 62 MAGE A3 ASCI 62 IIa trial 62 tanespimycin 62 successfully commercialize Iluvien 62 Exelbine NDA 62 EDEMA3 62 ANCHOR trial 62 sNDA filing 62 Trofex 62 Prestara 62 Troxatyl 62 Fx #A 62 Phase III TRIST 62 Increlex R 62 VitiGam 62 Fast Track designation 62 Preotact 62 forodesine 62 Anturol TM 62 zileuton CR 62 Phase 2b study 62 EOquin 62 NUVIGIL 62 EGS# 62 Allovectin 7 ® 62 Zerenex 62 Phase #/#a 62 Personalized Immunotherapy 61 Onrigin 61 Dyloject TM 61 PDX pralatrexate 61 placebo controlled Phase III 61 dose escalation Phase 61 tramiprosate Alzhemed TM 61 Cerashield 61 CLARITY study 61 Phase IIb trial 61 clinical pharmacology studies 61 Nabi HB Intravenous 61 Hedgehog antagonist 61 ularitide 61 AeroLEF TM 61 liprotamase 61 opioid induced bowel dysfunction 61 OvaRex R 61 Dalbavancin 61 supplemental Biologics License Application 61 DPX Survivac 61 Zenvia ™ 61 StaphVAX 61 Veronate 61 voclosporin 61 vernakalant oral 61 pixantrone NDA 61 Nebido 61 Phase 1a 61 JAK inhibitor 61 Phase III pivotal 61 Cimzia TM 61 proprietary transdermal patch 61 IND CTA 61 deforolimus 61 eprodisate Fibrillex TM 61 THALOMID 61 SILENOR 61 FIRAZYR 61 Phase 1b 61 pharmacokinetic studies 61 randomized controlled Phase 61 RSD# oral 61 PEARL SC 61 OMAPRO 61 EGRIFTA TM 61 ONCONASE 61 Sym# 61 Phase IIIb 61 TACI Ig 61 Centralized Procedure 61 vosaroxin 61 FRDA 61 bazedoxifene 61 PNT# 61 Raptiva R 61 Alzhemed TM 61 WILEX 61 TOCOSOL Paclitaxel 61 interferon gamma 1b 61 SinuNase TM 61 AERx iDMS 61 MAXY VII 61 JZP 61 Marketing Authorization Applications 61 BiovaxID TM 61 SYMMETRY trial 61 anticancer compound 61 Phase IIb trials 61 Vilazodone 61 Actimmune ® 61 Ereska 61 Stimuvax R 61 phase IIa 61 ataluren 61 bardoxolone 61 investigational humanized monoclonal antibody 61 BRIM3 61 investigational therapies 61 Cloretazine ® 61 BLOOM DM 61 enzastaurin 61 ezogabine 61 CEQ# 61 R#/MEM # 61 LEVADEX ™ 61 Phase IIb clinical 61 incyclinide 61 lintuzumab 61 AEG# 61 Corlux 61 Iluvien ® 61 generation purine nucleoside 61 Files Investigational 61 GSK# [001] 61 Complete Response letter 61 Nanobody R 61 Surfaxin LS 61 Restanza 61 Phase 2b clinical 61 Proellex TM 61 PrevOnco 61 Phase IIb 61 atacicept 61 SURFAXIN 61 Cladribine Tablets 61 alvespimycin 61 brivaracetam 61 Specifid 61 Bronchitol 61 multicenter Phase II 61 TBC# 61 IV acetaminophen 61 ZADAXIN ® 61 Orazol 61 M Enoxaparin 61 Glybera 61 denosumab oncology 60 Loramyc R 60 FACTIVE R gemifloxacin 60 Dextofisopam 60 autologous cellular immunotherapy 60 RAPTIVA R 60 OFIRMEV 60 taliglucerase alfa 60 BYDUREON 60 Flutiform ™ 60 liver resection surgeries 60 Phase Ia 60 APEX AMI trial 60 generation URAT1 inhibitor 60 Actimmune R 60 granted Ortec 60 ANTEGREN 60 Genasense ® oblimersen 60 thymalfasin 60 ATryn ® 60 ONGLYZA ™ 60 Evoltra ® 60 LibiGel Phase III 60 LibiGel ® testosterone gel 60 Shigamabs R 60 GEM #S 60 TMC# [002] 60 dosing cohort 60 Phase #b/#a trial 60 GRAS notification 60 Bezielle 60 Targretin capsules 60 AZILECT R 60 PHX# 60 Fibrin Pad 60 PROGENSA R 60 PrevOnco ™ 60 ganaxolone 60 albinterferon alfa 2b 60 pharmacokinetic PK 60 prGCD 60 OraTest 60 PS# [001] 60 Emezine 60 Elagolix 60 Tarceva TM 60 Xanafide 60 oral calcitonin 60 postapproval 60 confirmatory clinical 60 LEUKINE 60 Silenor NDA 60 ZEVALIN ® 60 ridaforolimus 60 Biologics Licensing 60 huC# DM4 60 GLP toxicology 60 Cinryze TM 60 CAMPATH 60 Panzem R NCD 60 Phase 1b dose escalation 60 eTag assays 60 Alvesco R 60 Marketing Authorisation Application MAA 60 Prodarsan R 60 BrachySil TM 60 TRIST study 60 Soliris TM eculizumab 60 otelixizumab 60 dalbavancin 60 PROMACTA 60 EndoTAG TM 60 Urocidin TM 60 midstage trials 60 lorvotuzumab mertansine 60 tiapamil 60 CONBRIZA 60 BEMA Fentanyl 60 Cethrin 60 KNS # 60 PFO migraine 60 Pivotal Phase III 60 MyVax 60 PEG PAL 60 Rhucin R 60 LymphoStat B 60 Phase Ib clinical 60 JOULFERON 60 Actilon 60 PCA3 test 60 Stedivaze 60 supplemental biologics 60 Topical Interferon Alpha 2b 60 Syncria 60 Ceflatonin ® 60 CHMP opinion 60 Stavzor 60 NP2 Enkephalin 60 MORAb 60 Panzem R 60 LibiGel ® 60 BLP# Liposome Vaccine 60 Biologic License Application 60 ADAGIO study 60 pulmonology portfolio 60 BEMA TM Fentanyl 60 Genasense ® 60 ongoing Phase IIIb 60 balsalazide tablet 60 omecamtiv mecarbil 60 TRISENOX 60 Arzerra TM 60 Orapred ODT 60 clinical trial 60 CINQUIL 60 Evoltra R 60 mertansine 60 Octreolin 60 ADVEXIN clinical 60 Rhucin 60 QNEXA 60 Orphan Drug status 60 Phase III Clinical Trial 60 GED aPC 60 AnGes 60 Traficet EN 60 Hematide ™ 60 Prostate AdenoCarcinoma Treatment 60 XmAb# 60 fidaxomicin Phase 3 60 Neo Kidney Augment 60 POSIDUR TM 60 AZD# TC 60 BST CarGel R 60 hoFH 60 ongoing Phase 1b 60 Phase 2a 60 pralatrexate 60 initiate Phase 1b 60 AVADO 60 rhThrombin 60 HepeX B TM 60 Sular formulation 60 Xcytrin R 60 Phase 2b clinical trials 60 valopicitabine 60 AZILECT ® 60 HuMax CD4 60 Optiquel ™ 60 Bioral Amphotericin B 59 Acetavance 59 trastuzumab emtansine T DM1 59 inhaled AAT 59 Augment Bone Graft 59 VITAL Trial 59 TAXUS Element Stent System 59 clinical endpoints 59 tafamidis 59 REPEL CV 59 CIMZIA TM 59 Prestara TM 59 severe hypercholesterolemia 59 OMP designation 59 severe gastroparesis 59 tubulin inhibitor 59 oral prodrug 59 ALTROPANE 59 Cetrorelix 59 phase IIb study 59 IMPACT IMmunotherapy 59 EDEMA4 59 methylnaltrexone 59 Tekturna HCT 59 Phase III Pivotal 59 CINTREDEKIN BESUDOTOX 59 DASISION 59 RECOTHROM R 59 RANK Ligand inhibitor 59 unblinding 59 HuMax TAC 59 MelaFind ® 59 liposomal formulation 59 Androxal TM 59 STEDESA 59 Zingo TM 59 SUTENT ® 59 Besivance 59 Hyphanox 59 registrational studies 59 INTERCEPT platelets 59 BioSTAR R 59 MoxDuo IR 59 StaphVAX R 59 Phase IIIb study 59 ALN TTR 59 TG MV 59 NDA Submission 59 RIGScan 59 CYCLOSET 59 EmbraceAC 59 Phase IIa 59 Phase III ADT 59 PSMA ADC 59 OLpur TM H2H 59 Approvable Letter 59 Iluvien 59 LymphoStat B belimumab 59 GetGoal Phase III 59 Tavocept 59 Somatuline R Depot 59 CDP# 59 Gamunex C 59 DPP4 59 Aphthasol R 59 ATPace 59 Phase III randomized controlled 59 velaglucerase alfa 59 CR# vcMMAE 59 FDA Accelerated Approval 59 GRNVAC1 59 LE SN# 59 ENTEREG ® 59 PhosLo 59 Neurodex 59 Kuvan 59 CCR5 mAb 59 Phase III confirmatory 59 sumatriptan DosePro 59 MERLIN TIMI 59 PROVIGIL 59 budesonide foam 59 Bicifadine 59 synthetic retinoid 59 regorafenib 59 cintredekin besudotox 59 VALSTAR 59 Tengion Neo Urinary Conduit 59 Phase III trials 59 Phase III 59 OncoVEX 59 Trobalt 59 PROMACTA CARES 59 Study GL# 59 AIMM trial 59 SYCREST 59 PRIMO CABG 59 omacetaxine mepesuccinate 59 Kynapid 59 RAPTIVA 59 Sulonex 59 DYNEPO 59 PDUFA date 59 active moiety 59 pafuramidine 59 omiganan 59 Oracea TM 59 tezampanel 59 Diamyd R 59 Genasense R oblimersen 59 PTK ZK 59 Onsolis 59 Ocrelizumab 59 PROVENGE ® 59 custirsen 59 InterfeRx 59 PI3K/Akt pathway inhibitor 59 PEG SN# 59 lucinactant 59 Zemplar Capsules 59 XP# XP# 59 Ixempra 59 Phase 2b 59 histamine dihydrochloride 59 CIP Fenofibrate 59 HepeX B 59 Microplasmin 59 Teysuno 59 celgosivir 59 Zenvia Phase III 59 Zemiva ™ 59 MEND CABG II 59 ZOLINZA 59 Neo Urinary Conduit 59 Cloretazine R VNP#M 59 KRYSTEXXA TM pegloticase 59 Phase 1b clinical trials 59 Exelixis compounds 59 BCX# 59 phase Ib 59 perifosine KRX 59 Entereg R 59 SEPET TM 59 rNAPc2 59 DCVax R Prostate 59 ELND# 59 bioequivalency 59 RSR# 59 Ganite ® 59 PROMUS Element Stent 59 pediatric acute lymphoblastic 59 tesmilifene 59 MelaFind R 59 docetaxel Taxotere R 59 IIa trials 59 ALN PCS 59 PROMACTA ® 59 omacetaxine 59 Orphan Drug Status 59 cannabinor 59 initiate Phase IIb 59 Zalbin 59 OLEPTRO 59 Increlex TM 59 Combidex 59 TRANSDUR Bupivacaine 59 Xcellerated T Cells 59 fostamatinib 59 MethyPatch 59 Evoltra TM 59 Phase IIa clinical 59 Tezampanel 59 Nasulin 59 Phase 2a clinical 59 SAR# [004] 59 Premarket Approval 59 TKM ApoB 59 Phase III Clinical Trials 59 Exherin TM 59 MBP# [001] 59 HoFH 59 PREGNANT Study 59 Asentar 59 Ketotransdel 59 IND enabling 59 KIACTA ™ 59 HepaSphere 59 vemurafenib 59 ISO Vorin TM 59 Manja Bouman CEO 59 MNTX 59 denufosol 59 RiVax ™ 59 LEP ETU 59 PRECISE Trial 59 obatoclax 59 Frova ® 59 Panzem 59 Kamada AAT 59 phase 2a 59 ORTHOVISC mini 59 Phase 2b kidney transplant 59 NEO3 59 cystinosis patients 58 TPI ASM8 58 CryoSeal FS System 58 AA amyloidosis 58 FORTIS M trial 58 sevelamer carbonate 58 Ilaris 58 Nanobody 58 bevasiranib 58 Shire BioChem Inc. 58 Exocrine Pancreatic Insufficiency 58 SUPPRELIN LA 58 IRX 2 58 G#DT 58 CytoFabTM 58 Onalta ™ 58 ALN VSP 58 aflibercept 58 Visian Toric ICL 58 OvaDx 58 Altropane 58 Ostarine 58 leading oral taxane 58 EchoCRT 58 rThrombin 58 sargramostim 58 TYZEKA 58 BENLYSTA ® 58 INSPIRE Trial Phase III 58 CLIA waiver 58 PXD# 58 Application BLA 58 Vectibix panitumumab 58 TELCYTA 58 HGS# 58 SinuNase 58 iChem ® VELOCITY 58 Ceplene histamine dihydrochloride 58 Insegia 58 ORENCIA R 58 Loramyc ® 58 ALN VSP Phase 58 RESTORE CLI trial 58 ganetespib 58 dose cohort 58 Sulonex TM 58 European Sepsis Trial 58 Phase Ib clinical trials 58 phase III isavuconazole 58 ANDA submission 58 Preos 58 Rotarix R 58 BEMA Granisetron 58 GEM OS2 58 Anturol ® 58 romiplostim 58 NOX E# 58 Valortim 58 Marketing Authorisation 58 SANVAR 58 Somatuline Depot 58 BENLYSTA 58 VEGF Trap 58 Omapro 58 INDs 58 HDAC Inhibitor 58 Market Approval PMA 58 Telavancin 58 oral taxane 58 including eniluracil ADH 58 ULTRASE 58 AP# [003] 58 neratinib 58 Pivotal Trial 58 Neo Bladder Augment 58 orally administered inhibitor 58 TELINTRA 58 OMAPRO ™ 58 AZX# 58 Act PDUFA date 58 hyaluronidase enzyme 58 Daclizumab 58 lomitapide 58 ZEGERID Chewable Tablets 58 ThermoDox ® clinical 58 budesonide MMX Phase III 58 Flutiform TM 58 Spiegelmer ® 58 Oncaspar 58 BRIM2 58 vidofludimus 58 Romiplostim 58 danoprevir 58 BioNumerik 58 ELADUR 58 Theratope 58 mesylate tablets 58 MEPACT 58 HCD# [002] 58 dose escalation phase 58 TRISENOX ® 58 dacetuzumab 58 Cimzia ® certolizumab pegol 58 Gestiva TM 58 TREANDA 58 Phase 1b clinical 58 Velcade bortezomib 58 Urocortin 2 58 dose escalation clinical 58 orphan medicinal product 58 Exforge HCT 58 Lenocta 58 Mipomersen 58 Factor VIIa 58 Leukine 58 Multiple Ascending Dose 58 Lucanix R 58 unique alkylating agent 58 PDUFA Date 58 Oncotype DX colon cancer 58 eliglustat tartrate 58 Staphylococcus aureus Polysaccharide Conjugate 58 NeuVax 58 dosing cohorts 58 ZEGERID Powder 58 rhFVIIa 58 APEX PD 58 Locteron ® 58 SinuNase ™ 58 Probuphine 58 rALLy 58 LymphoStat B TM 58 Triolex 58 Q#IR 58 CHAMPION PCI 58 rhC1INH 58 Clolar ® 58 targeted radiotherapeutic 58 HspE7 58 Argatroban 58 ADVANCE PD 58 Intermezzo R 58 Anthim 58 pain palliation 58 NV1FGF 58 mifamurtide 58 investigational monoclonal antibody 58 OncoVEX GM CSF 58 Thorough QT 58 OLEPTRO TM 58 Vernakalant 58 IONSYS TM 58 Dacogen decitabine 58 elagolix 58 ALGRX 58 Marketing Authorization 58 Ganite R 58 nitric oxide donating prostaglandin 58 Thelin TM 58 acyclovir Lauriad ® 58 Orphan Drug designations 58 Canvaxin TM 58 EMPOWER ™ 58 Altastaph 58 Plenaxis R 58 ALN RSV# 58 multicenter clinical trials 58 eniluracil 58 IoGen 58 LensAR Laser System 58 Glufosfamide 58 drug ISA# 58 apaziquone 58 Mepact 58 BioMarck 58 candidate epratuzumab 58 Xenazine ® 58 OLYMPIA registry 58 AMEVIVE 58 CINOD 58 IMC #B 58 multicenter Phase 58 rPA anthrax vaccine 58 FIRMAGON R 58 tezampanel NGX# 58 Contrave NDA 58 glucokinase activator 58 dose cohorts 58 Vicinium TM 58 ONSOLIS 58 refractory chronic lymphocytic 58 TEMODAL 58 Orphan Status 58 LUVENIQ 58 SUTENT 58 arzoxifene 58 ILUVIEN ® 58 TRANSDUR Sufentanil 58 PIX# [002] 58 TransVax TM 58 Lymphoseek ® 58 GATTEX ® 58 PROSTASCINT R 58 Phase III HEAT 58 Symphony tCGM System 58 ASPIRE HIGHER 58 varespladib 58 INT# [002] 58 LUNESTA TM 58 efficacy endpoint 58 viral kinetic 58 novel oral anticoagulant 58 Eligard ® 58 Poly ICLC 58 KIACTA TM 58 ALN TTR# 58 Clinical Trial Application 58 Onconase 58 Strativa 58 oral salmon calcitonin 58 ENDEAVOR III 58 Initiate Clinical Trial 58 candidate REP# 58 PRESEPT 58 OHR/AVR# 58 Locteron 58 ofatumumab 58 Teflaro 58 Cloretazine 58 MGd 58 Orphan Drug Designation 58 Zenpep 58 GLPG# 58 Onrigin TM 58 non nucleoside HCV 58 AIM HIGH 58 crizotinib PF # 58 ixabepilone 58 VALOR trial 58 adecatumumab MT# 58 Fabry Disease 58 IV APAP 58 Advexin 58 Pivotal Clinical Trial 58 Torisel 58 glufosfamide 58 Priority Review 58 LIALDA 58 Angiox ® 58 BAY #-# 58 ApoB SNALP 58 bicifadine 58 CORTOSS 57 Anturol 57 postoperative ileus POI 57 RHUCIN 57 FDA Complete Response 57 ORBIT II 57 ICA # 57 Acetavance TM 57 SILENOR ™ 57 markets HP Acthar 57 Sutent sunitinib 57 Medidur FA 57 adult chronic ITP 57 Octreotide 57 product platforms AZX# 57 Testosterone MDTS ® 57 RELOVAIR ™ 57 MYDICAR ® 57 Orthopedic Advisory Panel 57 sunitinib malate 57 OrCel R 57 Pimavanserin 57 ToGA 57 ONTAK 57 PSN# [002] 57 AQ4N 57 maturation inhibitor 57 Hycamtin 57 XL# anticancer compounds 57 Chemophase 57 diabetic neuropathic pain 57 ospemifene 57 MAXY G# 57 vinflunine 57 Adnectin 57 CUSTOM III 57 Prodarsan 57 novel histone deacetylase 57 OMNARIS Nasal Spray 57 eltrombopag 57 Hedgehog Pathway Inhibitor 57 Kosan dependence