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Medical-imaging company Imagion Biosystems Lodges IND with FDA for Phase 2 Trial of MagSense® HER2 targeted imaging agent
MELBOURNE, Australia--(BUSINESS WIRE)--Imagion Biosystems, Ltd. announced that the company has lodged an IND application with the FDA for its MagSense® targeted imaging agent....
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CardioFocus Announces Late-Breaking Data at AF Symposium 2026 and Expands Pulsed Field Ablation Clinical Programs
MARLBOROUGH, Mass.--(BUSINESS WIRE)--CardioFocus Announces Late-Breaking Data at AF Symposium 2026 and Expands Pulsed Field Ablation Clinical Programs...
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Southern Research, Pathogenus Create Global Partnership
BIRMINGHAM, Ala.--(BUSINESS WIRE)--Southern Research and London-based Pathogenus Consulting have signed a three-year partnership that will allow both organizations to capitalize on growing research opportunities around the world. "We’ve seen clear momentum in our work with partners outside the United States, especially with Japan and European pharmaceutical companies, and the opportunity to broaden that footprint is both exciting and timely,” said Fusataka Koide, senior director of global clien...
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CareDx to Present AlloHeme™ Pivotal Clinical Validation Data in Hematologic Cancer Relapse Detection at 2026 Tandem Meetings
BRISBANE, Calif.--(BUSINESS WIRE)--CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high‑value healthcare solutions for transplant patients and caregivers, today announced that pivotal clinical validation data from the ACROBAT study (NCT04635384) will be presented at the 2026 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ASTCT™ and CIBMTR®,...
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Endospan Announces Positive One-Year Data from TRIOMPHE FDA Pivotal Study For the NEXUS® Aortic Arch Stent-Graft System
TEL AVIV, Israel--(BUSINESS WIRE)--Endospan, a privately held company pioneering solutions for the endovascular repair of aortic arch disease, today announced the one-year results of their TRIOMPHE Investigational Device Exemption (IDE) Study evaluating the NEXUS® Aortic Arch Stent-Graft System presented during the Society of Thoracic Surgeons (STS) Annual Meeting in New Orleans. TRIOMPHE is a prospective, multicenter, three-arm trial designed to assess the safety and effectiveness of the NEXUS...
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Cycle Pharmaceuticals Completes Acquisition of Applied Therapeutics
CAMBRIDGE, England & DETROIT--(BUSINESS WIRE)--Cycle Group Holdings Limited (“Cycle”) is delighted to announce it has completed the acquisition of NASDAQ-listed Applied Therapeutics, Inc. (NASDAQ: APLT; “Applied”), a clinical-stage biopharmaceutical company. Applied’s lead drug candidate, govorestat, is a novel central nervous system (CNS) penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Classic Galactosemia, Charcot-Marie-Tooth Sorbitol Deh...
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Quanterix Announces FDA 510(k) Submission for a Multi-Analyte Algorithmic Blood Test for Alzheimer’s Disease Detection
BILLERICA, Mass.--(BUSINESS WIRE)--Quanterix Corporation (Nasdaq: QTRX), a company transforming healthcare by accelerating biomarker breakthroughs from discovery to diagnostics, today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for a multi-analyte algorithmic blood test for Alzheimer’s disease (AD). This submission represents a significant milestone in the Company’s mission to provide superior, non-invasive, high-performance diagnost...
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Spruce Biosciences Adds Regulatory and Clinical Development Expertise to Leadership Team
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced the appointments of Daven Mody, Pharm.D., as Senior Vice President of Regulatory and Quality and Bruno Gagnon, B.Pharm., M.Sc., as Senior Vice President, Clinical Development Operations. “We are delighted to welcome both Daven and Brun...
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Estrella Immunopharma Announces Late-Breaking Oral Presentation of Phase 1 STARLIGHT-1 Data for EB103 at the 2026 Tandem Meetings of ASTCT® & CIBMTR®
EMERYVILLE, Calif.--(BUSINESS WIRE)--Estrella Immunopharma, Inc. (Nasdaq: ESLA) (“Estrella” or the “Company”), a clinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced its STARLIGHT-1 phase I result will be orally presented at the 2026 ASTCT & CIBMTR Tandem Meetings (American Society for Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Researc...
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CDR-Life Appoints Dimitrios Chondros, MD, as Chief Medical Officer
ZURICH--(BUSINESS WIRE)--CDR-Life, Inc., a clinical-stage biotechnology company developing highly selective T cell engagers (TCEs) to treat cancer and autoimmune diseases, today announced the appointment of Dimitrios Chondros, MD, as Chief Medical Officer. As Chief Medical Officer, Dr. Chondros will oversee CDR-Life’s clinical development, clinical operations, medical affairs and translational strategy. His appointment follows a period of significant progress for CDR-Life, as the company contin...