iPS Cells & Regenerative Medicine Weekly Report July 5, 2026

iPS Cells & Regenerative Medicine Weekly Report August 23, 2026

FDA Releases Draft GDUFA/PDUFA Reauthorization Letters, Committing to Strengthen Cell and Gene Therapy Program and Leverage Real-World Evidence

NurExone Accelerates U.S. Market Entry with GMP Exosome Manufacturing Partnership with Made Scientific, Targeting First Batch by H1 2027

FDA Finalizes Q&A Guidance on Cell and Gene Therapy Product Development, Clarifying Regulatory Review, CMC, and Safety Monitoring

Xellsmart Secures FDA Fast Track Designation for Parkinson’s iPSC-Derived Cell Therapy, Accelerating CNS Pipeline

Cellistic CTO Highlights Japanese Conditional Approvals for Cardiac and Parkinson’s iPSC Products, Outlining Path to Commercial-Scale iPSC Cell Therapy Manufacturing

Ultragenyx’s Genglycos Secures FDA Approval as First Gene Therapy for GSDIa – Bolstering In-House Manufacturing and Long-Term Post-Marketing Monitoring

Ultragenyx’s Genglycos Receives FDA Accelerated Approval as First Gene Therapy for Glycogen Storage Disease Type Ia, Requiring 10-Year Post-Marketing Monitoring