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FDA Removes REMS on CAR T Therapies – Boosts Community Access
The FDA has eliminated Risk Evaluation and Mitigation Strategies (REMS) for six approved CAR T cell therapies targeting BCMA and CD19 in multiple myeloma and certain leukemias and lymphomas. This...
FDA Accelerates Dizal’s Lung Cancer Drug Approval Amid Competition
Dizal Pharmaceutical received FDA accelerated approval for sunvozertinib (Zegfrovy), an oral EGFR exon 20 insertion mutation inhibitor for advanced non-small-cell lung cancer post chemotherapy....
Gene Editing Removes Down Syndrome Chromosome in Cells
Japanese researchers led by Dr. Ryotaro Hashizume successfully used CRISPR-Cas9 to remove the extra chromosome 21 responsible for Down syndrome in lab-grown human stem and skin cells....
Climate Change’s Early Fingerprints Traced via Thought Experiment
A novel thought experiment utilizing state-of-the-art climate model simulations has revealed how and when unequivocal signals of human-caused climate change could have been first detected since...
Artificial Intelligence Enhances Pathology and Genomic Predictions
AI and machine learning models are advancing multiple facets of biomedical research and healthcare. Notably, an AI framework developed by Karolinska Institutet and Yale University improves...
Innovations in Cancer Immunotherapies and Targeted Treatments
Novel immunotherapeutic approaches and targeted drug candidates show promise across several cancer types. Researchers are engineering CAR T cells with endogenous promoter control to selectively...
Stem Cell and Regenerative Medicine Breakthroughs
Significant progress marks regenerative medicine through advanced stem cell technologies. Researchers engineered aligned mesenchymal stem cell sheets that markedly increase secretion of reparative...
Novel Diagnostics and Therapeutics in Infectious and Metabolic Diseases
Emerging technologies are reshaping diagnosis and treatment of infectious and metabolic conditions. B7-H3 targeted antibody-drug conjugate ICP-B794 received IND clearance in China, advancing...
Cutting-Edge Materials and Technologies for Biomedicine and Energy
Innovation at the intersection of material science and biotechnology progresses with new breakthroughs. Researchers created water-insensitive near-infrared down-shifting nanoparticles enhancing...
Biotech Funding and Industry Challenges Amid Regulatory and Market Dynamics
The biotech sector faces a challenging funding environment amid regulatory shifts and market uncertainties. Year-to-date capital raises for biopharma companies reveal mixed investment trends, and...
FDA Removes CAR T Therapy Risk Guardrails... Community Shift Accelerates
The FDA has eliminated Risk Evaluation and Mitigation Strategies (REMS) for six CAR T therapies targeting BCMA and CD19 antigens used in multiple myeloma and certain leukemias and lymphomas. This...
Dizal's Lung Cancer Pill Gains FDA Nod Ahead of PDUFA Date
Dizal Pharmaceutical's sunvozertinib (Zegfrovy) received accelerated approval from the FDA for treating adults with metastatic non-small-cell lung cancer harboring EGFR exon 20 insertion mutations...
CRISPR Erases Extra Chromosome in Down Syndrome Cells
Japanese researchers at Mie University have demonstrated the first use of CRISPR-Cas9 gene-editing technology to selectively remove the trisomy 21 chromosome responsible for Down syndrome in...
AI Model AlphaGenome Unifies Genome Variant Effect Predictions
Google DeepMind unveiled AlphaGenome, an AI foundation model that predicts the effects of genetic variants on multiple molecular genomic properties, including gene expression, splicing, and...
Engineering Gut Bacteria to Detoxify Toxic PFAS Chemicals
Scientists discovered that nine strains of human gut bacteria can effectively accumulate per- and polyfluoroalkyl substances (PFAS), notorious 'forever chemicals' with significant health risks....
Breakthrough Method Generates Lung Cells Without Stem Technology
Researchers in Japan have developed a novel technique to swiftly produce lung alveolar epithelial type 2-like cells from mouse embryonic fibroblasts without employing stem cell technologies. This...
FDA Approves Regeneron’s Multiple Myeloma Drug Lynozyfic
Regeneron Pharmaceuticals received FDA approval for Lynozyfic, a bispecific antibody for multiple myeloma treatment, distinguished by enhanced dosing flexibility over competitors from Johnson &...
Advances in Cancer Research Identify Molecular Drivers and Biomarkers
Multiple studies have revealed key molecular targets that drive cancer progression and may improve diagnostics. Insights include: the role of S100A4 in liver cancer metastasis via NMIIa...
CAR T Cell Therapies Show Enhanced Tumor Penetration and Immune Modulation
Cutting-edge research focuses on improving the delivery and efficacy of CAR T cell immunotherapies in solid tumors. Breakthroughs include gene engineering methods to armor CAR T cells with...
Synthetic DNA Nanoparticles Accelerate Gene Therapy Screening
Dr. Divita Mathur’s team at Case Western Reserve University has pioneered synthetic DNA nanoparticles facilitating efficient intracellular delivery and gene editing, supported by a National...