X-Therma Announces XT-Thrive® Drug Master File (DMF) Accepted by U.S. Food and Drug Administration (FDA)
X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, announces that the Food and Drug Administration (FDA) accepted a Drug Master File (DMF) covering its product, XT-Thrive®. This DMF covers the Chemistry, Manufacturing and…
First Patient Treated in Phase 2 GvHD Trial
Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, confirms that the first patient has been enrolled and treated in its Phase 2 clinical trial of CYP-001 in high-risk acute graft versus host disease (aGvHD). CYP-001 is…
Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma
Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-619 in relapsed/refractory multiple myeloma. CLN-619 is a potential first-in-class…
CDR-Life Announces FDA Clearance of IND Application for CDR404 for Treatment of Solid Tumors
CDR-Life Inc. today announced the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for CDR404, its lead program in development as a precision immunotherapy for solid tumors. First of its kind, CDR404 is…
Medivir´s licensee, Tango Therapeutics, has dosed the first patient with TNG348, a novel USP1 inhibitor, in a phase 1/2 clinical study
Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that Medivir’s licensee, Tango Therapeutics (NASDAQ: TNGX; Tango), has dosed the first patient with TNG348, a novel…
SystImmune, Inc. Announces the Presentation of Breast Cancer Clinical Trial Results at the 2023 San Antonio Breast Cancer Conference and US Clinical Trial Developments
SystImmune, Inc (SystImmune), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) authorized the company to proceed with the planned clinical study of the HER2-specific HIRE platform ADC, BL-M07D1, in the Investigational New Drug (IND) application…
Synthego Bridges Critical Preclinical Gap to Accelerate CRISPR-based Cell and Gene Therapies
Synthego, a leading provider of genome engineering solutions, today announced the launch of its IND-enabling (INDe) gRNAs, a transformative product offering that revolutionizes the CRISPR-based cell and gene therapy preclinical pipeline. This innovative offering empowers researchers with high quality gRNAs…
