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Asia’s Evolving CGT Approvals and Access Landscape
Published in Cytotherapy (Review Article) Asia’s CGT sector continues to expand with fast-track pathways in Japan, Korea, China and Singapore while India and Thailand advance through flexible access models and domestic innovation. Approvals for CAR-T, stem cell and gene therapies are rising and pricing differences highlight how local manufacturing and regulatory maturity shape affordability and access. Regional collaboration and shared infrastructure are identified as key lev
Nov 20, 2025


Breakthrough in Stem Cell Fate Control
Published on: University of Colorado Boulder Scientists have found that manipulating cellular storage hubs called P bodies can rewind mature cells to a more flexible state and push them toward hard-to-generate lineages such as germ-cell-like or totipotent-like cells. The study shows how releasing specific RNAs from these structures reshapes cell identity, opening new possibilities for fertility treatment, organ regeneration, and early-stage disease modeling. 👉 Read the full
Nov 20, 2025


FDA Introduces New Pathway to Accelerate Personalized Gene Editing
Published on Endpoints News The FDA has unveiled a new “plausible mechanism pathway” to speed access to personalized gene editing therapies, inspired by the Baby KJ case. The approach aims to support rare disease treatment by allowing alternative trial designs while maintaining regulatory oversight. 👉 Read the full article: FDA unveils new path to speed personalized therapies, inspired by Baby KJ Disclaimer Images used are for illustrative purposes only and do not depict act
Nov 13, 2025


Patient Death Halts Intellia’s Phase 3 CRISPR Trial
Published on Fierce Biotech A patient in Intellia’s phase 3 trial of the CRISPR therapy nex-z has died following severe liver toxicity, prompting the FDA to keep both studies on hold. The company is investigating the liver signal and developing risk mitigation steps while monitoring all previously treated patients. 👉 Read the full article: Patient dies after receiving Intellia's CRISPR therapy Disclaimer Images used are for illustrative purposes only and do not depict actual
Nov 13, 2025


Researchers Uncover P Body Mechanism That Controls Stem Cell Fate
Published on University of Colorado Boulder CU Boulder scientists have discovered that P bodies act as organized RNA storage hubs that steer how stem cells decide their identity. By unlocking these structures, researchers were able to revert mature cells to earlier developmental states and generate germ-cell-like and totipotent-like cells with high efficiency. 👉 Read the full article: Scientists Discover New Way to Shape What a Stem Cell Becomes Disclaimer Images used are fo
Nov 13, 2025


Allogeneic NK Cell Platforms Advance Cancer Immunotherapy
Published on Cell & Gene New research highlights how allogeneic natural killer (NK) cell platforms are shaping the next phase of cancer immunotherapy. These off-the-shelf cell therapies promise broader access, faster deployment, and strong safety profiles across multiple tumor types. 👉 Read the full article: Building the Future of Cancer Immunotherapy Through Allogeneic NK Cell Innovation Disclaimer Images used are for illustrative purposes only and do not depict actual pers
Nov 8, 2025


Stem Cells Show Potential to Reverse Stroke Damage
Published on SciTechDaily Researchers report that transplanted stem cells may regenerate brain tissue and restore lost function after stroke. The study highlights early evidence of neuronal regrowth and recovery, marking a breakthrough in regenerative neurology. 👉 Read the full article: Stroke Damage Reversed as Stem Cells Regrow the Brain Disclaimer Images used are for illustrative purposes only and do not depict actual persons, products, or facilities. For full detail, ref
Nov 5, 2025


Strengthening Ethical and Professional Practice in Cell and Gene Therapy - Key Highlights from Malaysia’s Updated Guidelines
By Dr. Samuel Ting Chuo Yew President, Sarawak Society for Cell and Gene Therapy Research (SSCTR) The Ministry of Health Malaysia and the National Pharmaceutical Regulatory Agency (NPRA) have recently issued two landmark documents that define the national framework governing the use, research, and regulation of advanced cellular and genetic therapies in Malaysia. These are the “Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs)” publis
Oct 17, 2025


Global CGT Landscape: Q2 2025 Report Highlights
Published by ASGCT & Citeline The ASGCT Q2 2025 report shows sustained CGT momentum with new approvals in gene and mRNA therapies, steady deal activity, and rising oncology focus. M&A volume increased sharply, led by major pharma consolidations in advanced therapies. 👉 Read the full report: ASGCT Gene, Cell, & RNA Therapy Landscape Report Q2 2025 Disclaimer Images used are for illustrative purposes only and do not depict actual persons, products, or facilities. For full deta
Oct 15, 2025


Novo Nordisk to Acquire Akero Therapeutics for $5.2B
Published on LinkedIn (via Spencer Knight) Novo Nordisk has announced its plan to acquire Akero Therapeutics for up to $5.2 billion,...
Oct 12, 2025


Bristol Myers Squibb Acquires Orbital Therapeutics for $1.5B
Published on LinkedIn (via Spencer Knight) Bristol Myers Squibb announced a $1.5 billion acquisition of Orbital Therapeutics, advancing...
Oct 12, 2025


FDA Approves INLEXZO™, the First Drug-Releasing System for Bladder Cancer
Published on LinkedIn (via Spencer Knight) The FDA has approved INLEXZO™ (gemcitabine intravesical system) from Johnson & Johnson,...
Oct 12, 2025


FDA Issues Draft Guidance on Expedited Programs for Regenerative Medicine
Published on Holland & Knight The FDA has released new draft guidance outlining expedited pathways for regenerative medicine therapies....
Oct 12, 2025


Next-Generation CAR T Cells Overcome Solid Tumor Barriers
Published on Technology Networks Researchers at USC Norris and City of Hope engineered CAR T cells that deliver IL-12 fused to a PD-L1...
Oct 4, 2025


Experimental Low-Cost Cancer Therapies Challenge Market Models
Published on Bloomberg A new Bloomberg feature examines how experimental low-cost cancer treatments are reshaping debates around drug...
Oct 4, 2025


AskBio Begins Phase II Gene Therapy Trial for Parkinson’s in Europe
Published on Bayer Bayer’s AskBio has randomized the first European participants in its Phase II trial of AB-1005, an investigational...
Oct 4, 2025


First Parkinson’s Patient Dosed in Pivotal Phase III Cell Therapy Trial
Published on BlueRock Therapeutics BlueRock Therapeutics has treated the first Parkinson’s disease patient in its pivotal Phase III trial...
Oct 4, 2025


Scientists Explore New Ways to Reduce Risks in Stem Cell Therapy
Published on Phys.org Researchers are developing strategies to improve the safety of stem cell therapies, focusing on reducing potential...
Oct 4, 2025


FDA Issues New Guidance on Cell, Gene, and Regenerative Therapies
Published on RAPS The US FDA has released updated guidance documents covering cell and gene therapies and regenerative medicine. These...
Oct 1, 2025


Patient-Derived Dendritic Cell Therapy Targets Hard-to-Treat Cancers
Published on The Scientist Researchers are advancing patient-derived dendritic cell immunotherapy as a personalized cancer treatment. By...
Oct 1, 2025
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