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20170531 |
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BGB-A317 |
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20170530 |
ÁßÁõÀÇ ¾çÃø ºñ¿ëÁ¾ÀÌ ÀÖ´Â ¼ºÀο¡¼ À¯Áö Ä¡·á¿¡ Ãß°¡µÇ´Â 100 mg SC ¸ÞÆú¸®ÁÖ¸¿ÀÇ ÀÓ»ó À¯È¿¼º ¹× ¾ÈÀü¼ºÀ» Æò°¡ÇÏ´Â ¹«ÀÛÀ§ ¹èÁ¤, ÀÌÁß ´«°¡¸², ÆòÇ౺ Á¦ 3»ó ÀÓ»ó½ÃÇè |
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20170530 |
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FDA |
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Drug Name and
FDA Appl. # |
Active Ingredients |
Submission
Classification |
Company |
Approval Date |
ZERVIATE
NDA #208694 |
CETIRIZINE HYDROCHLORIDE |
½Å¿ë·® |
NICOX OPHTHALMICS INC |
05/30/2017 |
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EMA |
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Name |
Active Substance |
Therapeutic Area |
Dafe of
Authorisation
/ refusal |
Varuby |
rolapitant |
Cancer
Nausea
Vomiting |
20/04/2017 |
Pemetrexed Hospira UK Limited |
pemetrexed ditromethamine |
Carcinoma,
Non-Small-Cell Lung
Mesothelioma |
24/04/2017 |
Ivabradine Accord |
ivabradine hydrochloride |
Angina Pectoris
Heart Failure |
22/05/2017 |
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Clinical.gov ¹Ì±¹ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03174197 |
Atezolizumab (aPDL1) + Temozolomide and Radiation for Newly Diagnosed Glioblastoma (GBM) |
Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System
Glioblastoma
Gliosarcoma |
Drug: Temozolomide
Drug: Atezolizumab
Radiation: Radiation Therapy |
M.D. Anderson
Cancer Center
Genentech, Inc. |
Phase 1
Phase 2 |
NCT03173937 |
Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome |
Severe Aplastic Anemia
Hypo-Plastic MDS
Myelodysplastic Syndrome (MDS) |
Biological: CordIn(TM) |
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health Clinical Center (CC) |
Phase 1
Phase 2 |
NCT03173950 |
Immune Checkpoint Inhibitor Nivolumab in People With Select Rare CNS Cancers |
Ependymoma
Meningioma
Chordoma |
Drug: Nivolumab |
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC) |
Phase 2 |
NCT03172624 |
Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer |
Salivary Gland Cancer |
Drug: Nivolumab
Drug: Ipilimumab |
Memorial Sloan Kettering Cancer Center
Bristol-Myers Squibb |
Phase 2 |
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Clinical.gov Áß±¹ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03173417 |
Safety and Efficacy Evaluation of IM19 CAR-T Cells (IM19CAR-T) |
Leukemia |
Biological: IM19 CAR-T |
Beijing Immunochina Medical Science & Technology Co., Ltd. |
Phase 1
Phase 2 |
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Clinical.gov ÀϺ» |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03172819 |
Special Combination of OBP-301 and Pembrolizumab |
Advanced Solid Tumor |
Biological: OBP-301
Drug: Pembrolizumab |
Toshihiko Doi
Oncolys BioPharma Inc
National Cancer Center Hospital East |
Phase 1 |
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