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FDA  
Drug Name and
FDA Appl. #
Active Ingredients Submission
Classification
Company Approval Date

PALONOSETRON HYDROCHLORIDE
NDA #207364

PALONOSETRON HYDROCHLORIDE - SOMERSET THERAPS LLC 09/01/2017
ADMELOG
NDA #209196
INSULIN LISPRO ½ÅÁ¦Çü ¶Ç´Â ½ÅÁ¦Á¶¿ø SANOFI AVENTIS US 09/01/2017
TRACLEER
NDA #209279
BOSENTAN ½ÅÁ¦Çü ¶Ç´Â ½ÅÁ¦Á¶¿ø ACTELION PHARMACEUTICALS LTD 09/05/2017
   
 
 
 
Clinical.gov ¹Ì±¹
NCT
Number
Title Conditions Interventions Sponsor
/Collaborators
Phases
NCT03277729 Immunotherapy After Chemotherapy in Treating Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

CD20 Positive|Recurrent B-Cell Non-Hodgkin Lymphoma|Recurrent Chronic Lymphocytic Leukemia|Recurrent Diffuse Large B-Cell Lymphoma|Recurrent Follicular ...

Biological: Chimeric Antigen Receptor T-Cell Therapy
Drug: Cyclophosphamide
Drug: Fludarabine
Other: Laboratory Biomarker Analysis
Procedure: Leukapheresis
Fred Hutchinson Cancer Research Center|National Cancer Institute (NCI) Phase 1
Phase 2
NCT03277638 Laser Interstitial Thermotherapy Combined With Checkpoint Inhibitor for Recurrent Glioblastoma Glioblastoma, Adult

Drug: Pembrolizumab at 7 days prior
Drug: Pembrolizumab at 14 days post
Drug: Pembrolizumab at 35 days post
Procedure: Laser Interstitial Thermotherapy

Case Comprehensive Cancer Center

Phase 1 Phase 2

NCT03277261 A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) Relapsing Multiple Sclerosis (RMS) Biological: Ublituximab
Drug: Teriflunomide
TG Therapeutics, Inc. Phase 3
NCT03275597 Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Non-small Lung Cancer (NSCLC) With Dual Immune Checkpoint Inhibition Non-small Cell Lung Cancer|Non-small Cell Lung Cancer Stage IV Drug: Durvalumab
Drug: Tremelimumab
Radiation: Stereotactic
Body Radiotherapy
University of Wisconsin, Madison
AstraZeneca
National Cancer Institute (NCI)
Phase 1
NCT03274661 Pembrolizumab Activity in Patients With HR Competent and Deficient Tumors Solid Tumor, Adult Drug: Pembrolizumab 200 mg Q3W Baptist Health South Florida
Merck Sharp & Dohme Corp.
Miami Cancer Institute
Phase 2
NCT03274258 Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma Renal Medullary Carcinoma|Other Disorders of Kidney and Ureter Drug: Nivolumab
Drug: Ipilimumab
M.D. Anderson Cancer Center
Bristol-Myers Squibb
Phase 2
NCT03274219 Study of bb21217 in Multiple Myeloma Multiple Myeloma Biological: bb21217 bluebird bio Phase 1
NCT03277482 Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer Recurrent Gynecological Cancer
Metastatic Cervical Cancer
Metastatic Ovarian Cancer
Metastatic Vaginal Cancer
Metastatic Vulvar Cancer...
Drug: Durvalumab
Drug: Tremelimumab
Radiation: Radiation Therapy
Dana-Farber Cancer Institute
AstraZeneca
Phase 1
NCT03277248 A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compares to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 2) Relapsing Multiple Sclerosis (RMS) Biological: Ublituximab
Drug: Teriflunomide
TG Therapeutics, Inc. Phase 3
NCT03274492 A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma Diffuse Large B-Cell Lymphoma Drug: Polatuzumab Vedotin
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Vincristine Placebo
Drug: Prednisone
Drug: Polatuzumab vedotin Placebo
Hoffmann-La Roche Phase 3
Clinical.gov À¯·´


NCT
Number
Title Conditions Interventions Sponsor
/Collaborators
Phases ºñ°í
NCT03275636 Haploidentical Donor vs mMUD in Hematological Malignancies AML|ALL|MDS Biological: Peripheral blood stem cells DKMS gemeinnützige GmbH Phase 2
Phase 3
µ¶ÀÏ
NCT03276468 Evaluation of Atezolizumab-Venetoclax-Obinutuzumab Combination in Relapse/Refractory Lymphomas Follicular Lymphoma
Diffuse Large B Cell Lymphoma
Marginal Zone Lymphoma
Mucosa Associated Lymphoid Tissue
Drug: Atezolizumab
Drug: Obinutuzumab
Drug: Venetoclax
The Lymphoma Academic Research Organisation Phase 2 ÇÁ¶û½º
 
 
 
 
 

     
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