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FDA
Drug Name and
FDA Appl. #
Active Ingredients
Submission
Classification
Company
Approval Date
SYMJEPI
NDA #207534
EPINEPHRINE
½ÅÁ¦Çü ¶Ç´Â
½ÅÁ¦Á¶¿ø
ADAMIS PHARMACEUTICALS CORP
06/15/2017
CALCIUM GLUCONATE
NDA #208418
CALCIUM GLUCONATE
ÀÌ¹Ì ½ÃÆǵǰí ÀÖ´Â ÀǾàÇ°À̳ª
±âÁ¸¿¡ NDA·Î Çã°¡¹ÞÁö
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FRESENIUS KABI USA
06/15/2017
BAXDELA
NDA #208610
DELAFLOXACIN
½Å¹°Áú
MELINTA THERAPEUTICS INC
06/19/2017
Clinical.gov ¹Ì±¹
NCT
Number
Title
Conditions
Interventions
Sponsor
/Collaborators
Phases
NCT03190941
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*1101 Patients
Pancreatic Cancer
Gastric Cancer
Gastrointestinal Cancer
Colon Cancer
Rectal Cancer
Drug: Cyclophosphamide
Drug: Fludarabine
Biological:
anti-KRAS G12V mTCR
Drug: Aldesleukin
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
Phase 1
Phase 2
NCT03189706
Pilot Study of Chemoimmunotherapy for High-Risk Neuroblastoma
Neuroblastoma (NB)
Drug: Irinotecan
Drug: temozolomide
Biological: Hu3F8
Drug: GM-CSF
Memorial Sloan Kettering Cancer Center
Y-Mabs, Inc
Phase 1
Phase 2
NCT03190278
Phase I Study Evaluating Safety and Efficacy of UCART123 in Patients With Acute Myeloid Leukemia
Acute Myeloid Leukemia
Biological: UCART123
Cellectis S.A.
Phase 1
NCT03190213
Pembrolizumab for the Treatment of Recurrent High Grade Neuroendocrine Carcinoma
Neuroendocrine Tumors
Drug: Pembrolizumab Injection
University of Utah
Merck Sharp & Dohme Corp.
Phase 2
NCT03189238
A Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma (PRP) Peri-urethral and Clitoral Injections for the Treatment of Female Orgasmic Disorder
Female Orgasmic Disorder
Biological: Peri-urethral and clitoral injections
Center for Vulvovaginal Disorders
Phase 2
NCT03189030
Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer
Colorectal Neoplasms
Biological: pLADD
Aduro Biotech, Inc.
Hanlee P. Ji, MD
Phase 1
NCT03188510
A Study of Two Different Formulations of LY3074828 in Healthy Participants
Healthy
Biological: LY3074828
Eli Lilly and Company
Phase 1
NCT03186781
Influenza HA Ferritin Vaccine, Alone or in Prime-Boost Regimens With an Influenza DNA Vaccine in Healthy Adults
Influenza
Biological: VRC-FLUNPF081-00-VP (HA-F A/Sing)
Biological: VRC-FLUDNA082-00-VP (DNA A/Sing)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
Phase 1
NCT03187262
A Study of Daratumumab in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia
Waldenström Macroglobulinemia
Drug: Daratumumab
Dana-Farber Cancer Institute
Janssen, LP
Phase 2
Clinical.gov À¯·´
NCT
Number
Title
Conditions
Interventions
Sponsor
/Collaborators
Phases
NCT03187626
Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated to Splinting for Base-of-thumb Osteoarthritis
Base-of-thumb Osteoarthritis
Drug: botulinum toxin A
Drug: saline
Assistance Publique - Hôpitaux de Paris
URC CIC - Cochin
Phase 2
Phase 3
NCT03191786
A Study of Atezolizumab Compared With Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Containing Therapy
Non-Small Cell Lung Cancer
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Drug: Vinorelbine
Drug: Gemcitabine
Hoffmann-La Roche
Phase 3
NCT03191799
A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors
Hemophilia A
Drug: Emicizumab
Hoffmann-La Roche
Phase 3
Clinical.gov Áß±¹
NCT
Number
Title
Conditions
Interventions
Sponsor
/Collaborators
Phases
NCT03190811
Anti-PD-1 Alone or Combined With Autologous DC-CIK Cell Therapy in Advanced Solid Tumors
Neoplasms
Biological: Anti-PD-1 plus DC-CIK|Biological: Anti-PD-1 alone
Capital Medical University
Phase 1
Phase 2
NCT03188627
Autologous Bronchial Basal Cell Transplantation for Treatment of COPD
Chronic Obstructive Pulmonary Disease
Biological: Bronchial basal cells
Regend Therapeutics
Southwest Hospital, China
Tongji University
Phase 1
Phase 2
NCT03191773
A Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies
Acute Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Lymphoma
Combination Product: Drugs and anti-CD19 CAR transduced T cells
Second Affiliated Hospital of Guangzhou Medical University (and so on)
Phase 1
Phase 2
NCT03189160
A Study of PEG-somatropin Injection to Treat Children of Turner Syndrome
Turner Syndrome
Biological: PEG-rhGH low dose|Biological: PEG-rhGH high dose|Other: Non-treatment control group
GeneScience Pharmaceuticals Co., Ltd.|Beijing Children's Hospital (and so on)
Phase 2
Clinical.gov ÀϺ»
NCT
Number
Title
Conditions
Interventions
Sponsor
/Collaborators
Phases
NCT03188692
Phase 3 Study of BK1310
Intramuscular Injection in Healthy Infants
Immunization
Biological: DPT-IPV-Hib (Combined Vaccine)
Mitsubishi Tanabe Pharma Corporation|The Research Foundation for Microbial Diseases of Osaka University
Phase 3
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