Approval based on Phase III STARGLO study where Columvi in combination with chemotherapy showed a 41% reduction in the risk of death compared to MabThera/Rituxan plus chemotherapy1,2 DLBCL is an aggressive cancer with a high risk of progression meaning urgent and effective treatments are needed for people who relapse...
treatment News
BOSTON, Mass. & SHANGHAI, China – Eccogene, a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions, today announced that the first patient has been enrolled in MOSAIC, the company’s Phase 2a clinical trial evaluating ECC4703, ECC0509 and their combination in adults with MRI-based...
BOULDER, Colo. — Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designations for sevasemten for the treatment of Becker muscular dystrophy (Becker) and for the treatment of Duchenne muscular dystrophy (Duchenne). Sevasemten is an investigational...
BOULDER, Colo. — Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of Duchenne. EDG-5506 is an investigational orally administered small molecule designed to prevent contraction-induced muscle damage...
New open label data in Becker demonstrated sustained disease stabilization up to three years, reinforcing prior clinical findings Ongoing pivotal trial and FDA Type C meeting provide clear path to potential sevasemten registration as the first ever therapy for Becker Encouraging Phase 2 observations in Duchenne define the dose and...
BOULDER, Colo. — Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced its participation at the 2026 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. The Company will host a lunch forum with experts presenting Becker natural history data and discussing the need for community and definition...
BEIJING & CAMBRIDGE, Mass. – EdiGene, Inc. (“Company”, or “EdiGene”), today announced the first patient enrolled in multicenter Phase I clinical study of its investigational gene-editing hematopoietic stem cell therapy ET-01 for patients with transfusion dependent β-thalassemia at the Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC, and...
FUKUOKA, Japan — EditForce, Inc. (Headquarters: Fukuoka, Japan) is pleased to announce that a research paper on the results of a joint study with the research group led by Professor Masayuki Nakamori of the Department of Neurology of the Yamaguchi University Graduate School of Medicine, and Professor Hideki Mochizuki of the Department of Neurology of...
IRVINE, Calif. — Edwards Lifesciences (NYSE: EW) announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients. Approval of...
London, England – A drug candidate, based on pioneering UCL and Moorfields Eye Hospital research and currently under development by SIFI S.p.A., has been found to be highly effective in treating a rare sight-threatening eye infection in a new international clinical trial. The findings, published in Ophthalmology, describe the efficacy and...