FDA
– Preclinical data suggest combination of ziftomenib and imatinib has potential to resensitize patients to imatinib and induce durable responses – – Proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST to begin in 1H 2025 – Excerpt from the Press Release: SAN DIEGO, Aug. 08, 2024 (GLOBE NEWSWIRE) — Kura Oncology, Inc.…
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Excerpt from the Press Release: LOWELL, Mass., July 31, 2024 /PRNewswire/ — Alcyone Therapeutics Inc. (Alcyone), a clinical-stage biotechnology company pioneering next-generation precision genetic therapies and precision delivery solutions of therapies for complex neurological conditions, announced today that the U.S. Food and Drug Administration (FDA) has provided approval to continue enrollment of the PIERRE study (https://clinicaltrials.gov/ct2/show/NCT05866419) to…
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Alignment with FDA on Phase 3 study primary endpoint of Bayley-4 cognition and key secondary endpoint of Multi-Domain Responder Index (MDRI) Phase 3 study on track to initiate by the end of this year Excerpt from the Press Release: NOVATO, Calif., July 17, 2024 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced the…
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Community Health Network Has Begun Enrollment of the Prospective, Multi-Center Study to Assess the Real-World Clinical Impact of Galleri® in Addition to Currently Recommended Cancer Screenings Study Enrollment Includes Focus on Diverse and Underrepresented Populations Costs of Galleri and Related Items and Services for Study Participants Will be Covered by Medicare Excerpt from the Press Release:…
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First-in-human Phase 1a/1b clinical trial will evaluate orally available, RGT-61159 designed to selectively target MYB RNA and inhibit oncogenic MYB protein production Preclinical data supporting the clinical trial were recently presented at the American Society of Clinical Oncology Annual Meeting (ASCO 2024) Excerpt from the Press Release: WOBURN, Mass., July 10, 2024 /PRNewswire/ — Rgenta…
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Excerpt from the Press Release: PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / July 11, 2024 / Biophytis SA (Euronext Growth Paris:ALBPS), (“Biophytis” or the “Company”), a clinical-stage biotechnology company specialized in the development of therapeutics for age-related diseases, today announced that it has received Investigational New Drug (IND) approval from the Food and Drug…
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FDA clears CORUS™ PCSS for multilevel circumferential cervical fusion procedures based on results from the prospective, multicenter, randomized, controlled FUSE Study Excerpt from the Press Release: PLEASANTON, Calif., July 11, 2024 /PRNewswire/ — Providence Medical Technology announces FDA Clearance of its CORUS™ Posterior Cervical Stabilization System (PCSS) for the treatment of up to 3-level cervical…
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Excerpt from the Press Release: BERKELEY, Calif. and MAINZ, Germany, April 25, 2024 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today groundbreaking topline results from a pooled clinical study which included new patients and subjects from Mainz…
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Excerpt from the Press Release: SAN FRANCISCO, April 25, 2024 /PRNewswire/ — Freedom Biosciences, Inc. (“Freedom Bio” or the “Company”), a clinical-stage biotechnology platform focused on developing next-generation neuropsychiatric therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed with its FREE001-TRD-201 study for its lead program, FREE001,…
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Company advances towards their second clinical trial for SynKIR™ platform treating patients with Diffuse Large B Cell Lymphoma and other B-cell Non-Hodgkin Lymphoma subtypes who are relapsed or refractory after standard of care, including CAR T therapies Excerpt from the Press Release: PHILADELPHIA, April 3, 2024 /PRNewswire/ — Verismo Therapeutics, a clinical-stage CAR T company developing…
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