FDA

GRAIL Announces First Participant Enrolled in REACH Study Evaluating Clinical Impact of Galleri® Multi-Cancer Early Detection (MCED) Test in the Medicare Population

07/23/2024

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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Rgenta Therapeutics Announces FDA Clearance of IND Application for RGT-61159, an Oral Small Molecule RNA Modulator Designed to Halt Disease-Driver MYB Production in Adenoid Cystic Carcinoma (ACC) and Colorectal Cancer (CRC)

07/19/2024

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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Biophytis Obtains IND Approval from the FDA to Start its Phase 2 OBA Study in Obesity

07/18/2024

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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Landmark Clinical Study Demonstrates Superiority of 3-Level Circumferential Cervical Fusion Over Anterior Cervical Fusion Alone

07/17/2024

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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Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next Generation Colorectal Cancer Diagnostic

05/01/2024

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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Freedom Biosciences Announces FDA Approval of IND Application for FREE001 in Patients with Treatment-Resistant Depression

04/30/2024

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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Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR™-310 in Relapsed/Refractory B-cell NHL

04/12/2024

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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eGenesis Announces World’s First Successful Transplant of Genetically Engineered Porcine Kidney in a Living Patient

04/01/2024

– Marks historic milestone and opens new frontier in transplantation to address kidney shortage affecting millions of patients globally – Transplant was conducted at Massachusetts General Hospital and authorized by the U.S. FDA under a single Expanded Access protocol Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–eGenesis, a biotechnology company developing human-compatible engineered organs to…

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Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma

03/07/2024

Company will initiate Phase 1 study of CLN-619 for relapsed or refractory multiple myeloma, first MICA/B antibody clinical study in hematologic malignancies Follows ongoing clinical study of CLN-619 alone and in combination with pembrolizumab in solid tumors, with anticipated updated clinical data in Q2 2024 Excerpt from the Press Release: CAMBRIDGE, Mass., March 01, 2024…

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NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity

02/09/2024

Preclinical Studies Show DA-1726 Elicits Superior Weight Loss Compared to Semaglutide (Wegovy™) and Similar Weight Loss Compared to Tirzepatide (Mounjaro™), While Consuming More Food Initiation of Phase 1 Clinical Trial Expected to Occur in the First Half of 2024 Excerpt from the Press Release: CAMBRIDGE, Mass., Feb. 1, 2024 /PRNewswire/ — NeuroBo Pharmaceuticals, Inc. (Nasdaq:…

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