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FDA Finalizes Q&A Guidance on Cell and Gene Therapy Product Development, Clarifying Regulatory Review, CMC, and Safety Monitoring
RAPS (Regulatory Affairs Professionals Society) USA Overview The U.S. FDA has released final FAQ guidance on developing cell and gene therapy (CGT) products, providing practical answers to common regulatory questions spanning regulatory ... -
Xellsmart Secures FDA Fast Track Designation for Parkinson’s iPSC-Derived Cell Therapy, Accelerating CNS Pipeline
Longevity.Technology UK Overview Xellsmart announced its allogeneic, off-the-shelf iPSC-derived cell therapy for Parkinson's disease has received FDA Fast Track designation, expected to accelerate its development program. Specializing in... -
Cellistic CTO Highlights Japanese Conditional Approvals for Cardiac and Parkinson’s iPSC Products, Outlining Path to Commercial-Scale iPSC Cell Therapy Manufacturing
The Medicine Maker UK Overview In an interview with The Medicine Maker, Stefan Braam, CTO of Cellistic, stated that the industry's main focus is the ability to consistently provide iPSC-based cell therapies at commercial scale for large ... -
Ultragenyx’s Genglycos Secures FDA Approval as First Gene Therapy for GSDIa – Bolstering In-House Manufacturing and Long-Term Post-Marketing Monitoring
Pharmaceutical Technology USA Overview Ultragenyx Pharmaceutical has received FDA accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), the first gene therapy targeting the root cause of the ultra-rare metabolic disorder,... -
Ultragenyx’s Genglycos Receives FDA Accelerated Approval as First Gene Therapy for Glycogen Storage Disease Type Ia, Requiring 10-Year Post-Marketing Monitoring
Pharmaceutical Technology USA Overview Ultragenyx Pharmaceutical announced that Genglycos (pariglasgene brecaparvovec-opnr), the first gene therapy for Glycogen Storage Disease Type Ia (GSDIa), has received FDA accelerated approval. This... -
Moffitt Cancer Center’s Dr. Yvonne Chen Proposes Novel Strategies to Overcome Tumor Microenvironment Barriers in Solid Tumors with Logic-Gated CAR T-Cells
Moffitt Cancer Center USA Overview Dr. Yvonne Chen of Moffitt Cancer Center has discussed new strategies to enhance CAR-T cell therapy for solid tumors, focusing on precise targeting with logic-gated CAR-T cells and reprogramming the tum... -
2026 ‘In Vivo CRISPR Medicine’ Symposium to Focus on Commercialization and Scalable Deployment of In Vivo Genome Editing
CRISPR Medicine News (CMN x CSGCT Virtual Symposium) USA Overview The upcoming 'In Vivo CRISPR Medicine: From Scientific Promise to Patients at Scale' virtual symposium on September 3, 2026, will highlight the transition of in vivo genom... -
CRDWC 2026 Symposium to Address CAR-T Challenges in Solid Tumors: Focus on Design, Manufacturing, and Safety Strategies
CRDWC 2026 (Cancer Research and Development Conference 2026) Unknown Overview The 2026 Cancer Research and Development Conference will host a symposium dedicated to expanding CAR-T cell therapy from hematological malignancies to solid tu... -
Next-Generation Bioinks Create New Opportunities in Tissue Engineering and Drug Discovery via 3D Bioprinting
ACS Publications USA Overview Advances in next-generation bioinks are significantly propelling the fields of tissue engineering and regenerative medicine through 3D bioprinting technology. These bioinks are essential for creating microen... -
Penn State Team Establishes Foundation for 3D Bioprinted Spheroids to Promote Bone Tissue Regeneration and Vascularization
Penn State News USA Overview An interdisciplinary team at Penn State University has laid the groundwork for 3D printing spheroids, small living cell clusters, capable of regenerating bone tissue following severe trauma or infection. Rese...
