FDA– tag –
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FDA Clears Clinical Trial for CAR T-Cell Therapy in Advanced Colorectal Cancer, Expanding Solid Tumor Reach
University of Colorado Anschutz USA Overview The U.S. Food and Drug Administration (FDA) has authorized researchers at the University of Colorado Anschutz to conduct a clinical trial for CAR T-cell therapy targeting advanced colorectal c... -
Cellipont Bioservices Supports Six Cell Therapy Programs Towards 2026 IND Filings, Highlighting CDMO Market Growth
Cellipont Bioservices (via Contract Pharma news) USA Overview Texas-based cell therapy CDMO Cellipont Bioservices announced it is supporting six client projects anticipated to reach Investigational New Drug (IND) submission in 2026. Thei... -
Fate Therapeutics to Present Encore Clinical Data for iPSC-Derived FT819 in Systemic Scleroderma
Fate Therapeutics, Inc. Investors USA Overview Fate Therapeutics will re-present clinical data for FT819, its iPSC-derived, off-the-shelf CAR T-cell product candidate, at the CCR – West 2026 conference. The data potentially shows early c... -
IV Exosome Therapy: Under Investigation for Cell Behavior Modulation and Anti-Inflammation, FDA Not Yet Approved
Sanger Wellness Center USA Overview Exosomes, tiny extracellular vesicles involved in intercellular communication, are being investigated for their potential to influence cell behavior, inflammatory pathways, tissue response, and recover... -
BrainChild Bio Secures $116M, Earns FDA Breakthrough Designations for CAR-T Therapy Against Pediatric Brain Cancer DIPG
Hoodline USA Overview BrainChild Bio, a biotechnology firm spun out of Seattle Children's Hospital, has raised $116 million to advance its novel CAR-T cell therapy for Diffuse Intrinsic Pontine Glioma (DIPG), a devastating pediatric brai... -
CRISPR Gene Editing: Engineering Durable Cures for Congenital Diseases through Stem Cell and Liver Targeting
Liv Hospital Turkey Overview CRISPR gene editing technology promises a revolutionary approach to fundamentally cure congenital diseases by precisely correcting underlying genetic errors. By targeting the liver and hematopoietic stem cell... -
FDA Launches ‘TEMPO’ Pilot Program, Allowing Generative AI Medical Devices from Cadence and Limbic to Reach Patients Pre-Authorization
Industry Events (STAT News) USA Overview The FDA has launched its 'TEMPO' pilot program, enabling generative AI medical devices, such as those from Cadence and Limbic, to reach patients before full marketing authorization. This innovativ... -
AI Revolutionizes Clinical Trials: FDA Advances Early-Stage Pilot Program, Optimizing Protocol Design and Patient Selection
pharmaphorum UK Overview Artificial Intelligence (AI) is fundamentally transforming clinical development, reducing risks and accelerating timelines by enabling hypothesis testing before trials commence. The FDA issued a Request for Infor... -
University of Illinois Research Demonstrates AI Potential to Resolve Clinical Drug Trial Challenges, Accelerating Drug Development and Improving Efficiency
Gies College of Business (University of Illinois Urbana-Champaign) USA Overview Research from the Gies College of Business at the University of Illinois reveals AI's potential to significantly enhance the efficiency of clinical drug tria... -
ProBio Establishes Cell and Gene Therapy CDMO Center of Excellence in Hopewell, New Jersey, Specializing in Plasmid DNA and Viral Vector Manufacturing
ProBio USA Overview ProBio has opened a Cell and Gene Therapy Center of Excellence in Hopewell, New Jersey, focusing on the development and GMP manufacturing of plasmid DNA and viral vectors. This new facility is designed to meet stringe...
