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NovelMed Receives FDA IND Approval for NM8074 (Ruxoprubart), the First Anti-Bb Alternative Pathway Blocker for Treating Primary Immunoglobulin A Nephropathy (IgAN): A Renal Disorder
December 02, 2024 08:30 ET | NovelMed Therapeutics Inc
--- The United States FDA Clears Initiation of a Phase II Efficacy Trial in Immunoglobulin A Nephropathy (IgAN) Patients: a renal disorder Up to 50% of IgAN patients with persistent proteinuria...
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Praxis Bioresearch Obtains FDA Clearance On the IND Application for Its Lead Candidate PRX-P4-003 In Alzheimer’s Disease Apathy
October 29, 2024 07:48 ET | Praxis Bioresearch, Inc.
LOS ANGELES, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Praxis Bioresearch reports that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for...
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Minovia Therapeutics Announces FDA Clearance of IND Application for a Phase Ib Clinical Trial of MNV-201 in Low Risk Myelodysplastic Syndrome
September 26, 2024 12:34 ET | Minovia Therapeutics
MNV-201 is a mitochondrial cell therapy product composed of autologous hematopoietic stem cells enriched with allogeneic mitochondria In pre-clinical studies, MNV-201 demonstrated improved...
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Biosplice Therapeutics Announces Initiation of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) Trial Sponsored by the National Cancer Institute (NCI)
September 12, 2024 07:00 ET | Biosplice Therapeutics, Inc.
Biosplice Announces Initiation of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) Trial Sponsored by the National Cancer Institute (NCI)
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Medigene Announces U.S. FDA Clearance of IND Application for MDG1015, a First-in-Class, Third Generation T Cell Receptor Engineered T Cell (TCR-T) Therapy for Multiple Solid Tumor Indications
September 05, 2024 08:00 ET | Medigene AG
Planegg/Martinsried, September 5, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor...
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60 Degrees Pharma Provides University of Kentucky with Right of Reference to ARAKODA® NDA in Support of SJ733 Phase IIb Study
August 12, 2024 09:12 ET | Sixty Degrees Pharmaceuticals
60 Degrees Pharma grants U of Kentucky a right of reference to ARAKODA® NDA for a Phase IIb trial combining SJ733 with tafenoquine to treat vivax malaria.
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Umoja Biopharma Announces FDA Clearance of IND Application for UB-VV111, a CD19 Directed in situ CAR T for Hematologic Malignancies
July 31, 2024 07:00 ET | Umoja Biopharma, Inc.
- UB-VV111 is potentially the first in situ generated CD19 chimeric antigen receptor (CAR)-T cell therapy to be evaluated in humans in the hematology setting - - First patient expected to be dosed by...
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Tiziana Life Sciences to Dose First Patient with Moderate Alzheimer’s Disease with Foralumab
June 26, 2024 07:00 ET | Tiziana Life Sciences Ltd.
Tiziana Life Sciences to Dose First Patient with Moderate Alzheimer’s Disease with Foralumab
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Sermonix Pharmaceuticals Announces Chinese Approval of Investigational New Drug Application for Lasofoxifene
June 06, 2024 09:00 ET | Sermonix Pharmaceuticals Inc.
IND approval in China allows Shanghai Henlius Biotech, Sermonix’s Chinese development partner for oral lasofoxifene, to enroll ELAINE-3 trial patients in ChinaUnder strategic collaboration agreement...
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TransCode Therapeutics Announces FDA Clearance To Initiate Phase 1/2 Clinical Trial with TTX-MC138 in Patients with Advanced Solid Tumors
April 15, 2024 09:00 ET | TransCode Therapeutics, Inc.
TransCode Therapeutics Announces FDA Clearance To Initiate Phase 1/2 Clinical Trial with TTX-MC138 in Patients with Advanced Solid Tumors