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FDA Removes REMS from CAR T Therapies — Industry Voices Optimism
The FDA has eliminated the Risk Evaluation and Mitigation Strategies (REMS) previously required for six approved CAR T cell therapies targeting BCMA and CD19 antigens, marking a significant shift...
FDA Accelerates Dizal's Lung Cancer Drug Approval Ahead of PDUFA
The FDA granted accelerated approval to Dizal Pharmaceutical's oral drug sunvozertinib (Zegfrovy) for adults with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20...
CRISPR Deletes Extra Chromosome in Down Syndrome Cells for First Time
A team at Mie University in Japan has successfully used CRISPR-Cas9 technology to selectively remove the extra chromosome 21 responsible for Down syndrome in laboratory-grown human cells. This...
AI Model AlphaGenome Integrates Multimodal Genomic Predictions
Google DeepMind introduced AlphaGenome, an AI foundation model that simultaneously predicts diverse genomic features such as gene expression, RNA splicing, chromatin accessibility, histone...
New Insights into Adult Human Neurogenesis Confirmed
Recent research has provided compelling evidence for the continued generation of new neurons in adult human brains, settling longstanding scientific debate. Using advanced techniques, scientists...
Gut Bacteria Show Promise in Binding Toxic PFAS Chemicals
Researchers have identified certain human gut bacterial strains capable of effectively sequestering perfluoroalkyl and polyfluoroalkyl substances (PFAS), commonly known as 'forever chemicals,'...
SynHG Project Launches Effort to Build Synthetic Human Genome
Led by University of Oxford Professor Jason Chin, the newly funded SynHG project aims to develop the technologies and methodology necessary to synthesize a complete human genome from scratch over...
Breakthroughs in Glioblastoma Vaccination Show Survival Benefits
A comprehensive meta-analysis published in Journal for Immunotherapy of Cancer demonstrates vaccination therapies' potential to improve outcomes in glioblastoma multiforme (GBM), an aggressive...
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...