FDA– tag –
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FDA Approves Non-Invasive Biomarker Imaging Technology for Early Cardiovascular Disease Detection with 98.4% Sensitivity via Retinal Scan
news-today.us USA Overview The FDA has approved a groundbreaking non-invasive biomarker imaging technology capable of detecting subtle vascular inflammation during routine health check-ups. This optical biosensor platform achieves 98.4% ... -
Dexcom Stelo Wins FDA Approval as First Prescription-Free OTC Continuous Glucose Monitor for Non-Insulin Users
Dexcom (via Facebook) USA Overview Dexcom's Stelo glucose biosensor system has received FDA approval as the first over-the-counter (OTC) continuous glucose monitor (CGM) for adults aged 18 and older who do not use insulin. This landmark ... -
China’s Hopstem Biotech Secures Nearly RMB 200 Million in Series C First Close to Advance iPSC Cell Therapy Pipeline Led by hNPC01
Insight, China's Pharmaceutical Industry China Overview China's Hopstem Biotech has completed the first close of nearly RMB 200 million (approximately $27.5 million USD) in Series C funding to advance its iPSC cell therapy pipeline, led ... -
Novartis’ CAR-T Cell Therapy Tisagenlecleucel Shows Durable Efficacy in Pediatric and Young Adult ALL
CancerNetwork USA Overview Novartis' CAR-T cell therapy, tisagenlecleucel (Kymriah), continues to demonstrate durable efficacy and safety in pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia ... -
Building Commercial Readiness in Advanced Therapies: Optimizing Supply Chain, Manufacturing, and Regulatory Strategy is Critical
The Medicine Maker Unknown Overview Achieving commercial readiness for Advanced Therapy Medicinal Products (ATMPs), particularly cell and gene therapy products, is an urgent industry imperative. This requires establishing robust supply c... -
IPS HEART Secures FDA Rare Pediatric Disease Designation for Muscular Dystrophy-Associated Cardiomyopathies, Accelerating Cardiac Regenerative Medicine Development
BioSpace USA Overview IPS HEART has received Rare Pediatric Disease Designation (RPDD) from the U.S. FDA for its iPSC-derived therapeutic candidate for muscular dystrophy-associated cardiomyopathies. This marks the company's 8th FDA regu... -
RiboX Therapeutics Receives FDA IND Clearance for RXIM002, the First Circular RNA-Based In Vivo CAR Therapy for Autoimmune Cytopenias
BioSpace USA Overview RiboX Therapeutics has received FDA Investigational New Drug (IND) clearance for RXIM002, a circular RNA (circRNA)-based in vivo CAR therapy targeting autoimmune cytopenias. RXIM002 is the first in vivo CAR therapy ... -
CDMO Capacity Crunch Persists in Cell and Gene Therapy Sector: Strategic Partnerships Crucial for Accelerating Innovation
Contract Pharma USA Overview The cell and gene therapy (CGT) sector faces a severe and persistent capacity crunch among Contract Development and Manufacturing Organizations (CDMOs), driven by soaring demand. This bottleneck significantly... -
Children’s Hospital Los Angeles Joins Multi-Center Trial for In Vivo CRISPR Gene Editing Therapy for Sickle Cell Disease
Children's Hospital Los Angeles (CHLA) Facebook USA Overview Children's Hospital Los Angeles (CHLA) has announced its participation in a multi-center clinical trial evaluating a novel CRISPR-based, direct gene editing therapy for sickle ... -
CRISPR Gene Editing Achieves Clinical Breakthroughs in Sickle Cell Disease Treatment
Liv Hospital Turkey Overview Clinical trials employing CRISPR gene-editing technology for sickle cell disease are reporting highly promising results, significantly reducing severe vaso-occlusive crises and transfusion dependency. Utilizi...
