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FDA Approves Thermo Fisher NGS Test as Companion Diagnostic for Lung Cancer
Thermo Fisher Scientific's Oncomine Dx Express Test, performed on the Ion Torrent Genexus Dx platform, received FDA approval as an in vitro diagnostic assay for the companion diagnostic use with...
FDA Removes REMS Program, CMS Sets Reimbursement for AI Cardiac Tool
The FDA has removed Risk Evaluation and Mitigation Strategies from several CAR T cell therapies, reducing regulatory requirements and facilitating broader use in clinical practice. Concurrently,...
FDA Removes Safety Restrictions on CAR T Therapies – Industry Sees Boost
The FDA has eliminated the Risk Evaluation and Mitigation Strategies (REMS) requirements for six approved CAR T cell therapies targeting BCMA and CD19 antigens, used in multiple myeloma and...
Dizal Gains FDA Nod for Lung Cancer Therapy Amid Competitive Race
Dizal Pharmaceutical received accelerated FDA approval for sunvozertinib (Zegfrovy), its targeted oral therapy for non-small cell lung cancer with EGFR exon 20 insertion mutations in patients...
Breakthrough CRISPR Technique Eliminates Extra Down Syndrome Chromosome
Scientists in Japan achieved a pioneering milestone by using CRISPR-Cas9 to selectively excise the third copy of chromosome 21 in human cells cultured in vitro, effectively removing the genetic...
Groundbreaking Adult Neurogenesis Evidence Resolves Longstanding Debate
A recent high-impact study leveraging innovative techniques unveils direct evidence of neural precursor cells and newborn neurons in adult human hippocampi, including in individuals up to age 78....
Google DeepMind Launches AlphaGenome: Unified AI Model for Genomic Variant Effects
Google DeepMind has unveiled AlphaGenome, a single AI foundation model that integrates multiple predictive tasks related to genomic variants. Trained on vast datasets, AlphaGenome forecasts...
AI Aids Pathologists in Skin Cancer Diagnosis Enhancing Accuracy and Consistency
A collaborative study between Karolinska Institutet and Yale University demonstrates that artificial intelligence assistance significantly improves pathologists’ accuracy and reproducibility in...
Novel Self-Healing UAV Skin Developed to Prevent Ice Accumulation and Enable Monitoring
Researchers introduced an innovative autonomous drone skin exhibiting self-healing capabilities to prevent ice buildup, a critical hazard for unmanned aerial vehicles operating in varied climates....
Meta-Analysis Affirms Aerobic Exercise Alleviates Fatigue in Colorectal Cancer Patients
A recent comprehensive meta-analysis published in BMC Cancer provides compelling evidence that aerobic exercise effectively reduces cancer-related fatigue among colorectal cancer patients. The...
Methdological Breakthrough: ‘scICE’ Tool Tackles Single-Cell RNA-seq Data Reliability
As single-cell RNA sequencing technologies deliver unprecedented insights into cellular heterogeneity, challenges in data reliability and reproducibility have surfaced. Researchers have developed...
Saudi Arabia Launches Ambitious National Biotechnology Strategy to Build Global Hub
In a strategic move linked to Vision 2030, Saudi Arabia has launched its National Biotechnology Strategy aimed at transforming the Kingdom into a regional and global biotech powerhouse. The plan...
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...