iPS Cells & Regenerative Medicine– category –
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iPSC 20th Anniversary: Japan Leads with Conditional Approvals, Facing Challenges of Public Trust and Universal Access
Facebook (Science Vibes) USA Overview The 20th anniversary of iPSC discovery highlights significant progress in regenerative medicine, with Japan leading globally by granting the world's first conditional approvals for iPSC-derived thera... -
Commercial-Scale iPSC Cell Therapy Production Gains Traction with US Clinical Trial Progress and Master Cell Bank Establishment
The Medicine Maker UK Overview Manufacturing challenges for commercial-scale iPSC cell therapies are being overcome, with multiple iPSC clinical trials progressing in the U.S. for indications like Type 1 Diabetes, Parkinson's disease, an... -
Next-Generation CRISPR Tools Revolutionize Precise Gene Editing, Bypassing Double-Strand Breaks for Enhanced Therapeutic Safety and Consistency
News-Medical.net USA Overview Next-generation CRISPR technologies are fundamentally transforming cell and gene therapy by enabling precise gene editing without relying on double-strand DNA breaks (DSBs). Advances in base editing, prime e... -
REPROCELL Pioneers Integrated iPSC Manufacturing Platform, Accelerating US Phase III Clinical Programs with AI-Enhanced Gene Editing and GMP Compliance
REPROCELL Japan Overview REPROCELL has launched a comprehensive iPSC manufacturing platform designed to accelerate the clinical development of iPSC-derived therapeutics, notably supporting a US Phase III program. The platform integrates ... -
iPS Cells & Regenerative Medicine Weekly Report August 23, 2026
▼ ▼ ▼ If the infographic makes you want to read the full report, please click the download button below. ▼ ▼ ▼ 📄 Weekly Report August 23, 2026 (PDF) — Download Weekly Report August 23, 2026 (PDF) — DownloadDownload 🎙 Podcast August 23, ... -
FDA Releases Draft GDUFA/PDUFA Reauthorization Letters, Committing to Strengthen Cell and Gene Therapy Program and Leverage Real-World Evidence
Holland & Knight USA Overview The U.S. FDA has released draft commitment letters for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) and Prescription Drug User Fee Act (PDUFA). These letters include the FDA's commitme... -
NurExone Accelerates U.S. Market Entry with GMP Exosome Manufacturing Partnership with Made Scientific, Targeting First Batch by H1 2027
BioPharma BoardRoom USA Overview Exo-Top Inc., a U.S. subsidiary of NurExone Biologic Inc., has signed an MOU with Made Scientific, Inc. for a GMP exosome manufacturing partnership in the U.S. This strategic alliance aims to accelerate N... -
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 ...
