🧬 This Week in Gene & Cell Therapy: FDA Shake-Up, Diabetes Cell Breakthroughs, RDEB Success and More
From FDA leadership changes to durable insulin independence, this roundup dives into the week’s most impactful developments in gene and cell therapy. Whether you’re tracking next-gen diabetes treatments, regenerative orthopedics, or orphan drug milestones—this episode delivers what matters. 🔬💡
🔍 Highlights in this episode:
⚖️ FDA leadership shake-up raises concerns about the future of gene therapy oversight
🌍 Zemcelpro receives positive CHMP opinion, moving closer to EU approval for blood cancers
🇰🇷 Korea selects Rznomics’ RZ-001 glioblastoma therapy for national drug development program
💉 Vertex’s VX-880 helps 10 of 12 diabetes patients become insulin-independent
🧪 Zimislecel shows 83 percent of participants off insulin after one year
🧠Neurona begins trial for bilateral drug-resistant MTLE using NRTX-1001
đź’Ş Deramiocel preserves heart and muscle function for 4 years in Duchenne patients
🧬 Rejuva gene therapy prevents obesity and diabetes in mice with a single dose
🦴 Carisma and OrthoCellix merge to drive Phase 3-ready NeoCart cartilage therapy
🧫 Sana’s islet cells produce insulin without immunosuppression or rejection
🧬 Sangamo’s Fabry therapy improves kidney function; BLA filing expected in Q1 2026
🧬 Cure Rare Disease advances CRD-003 for LGMDR9 with FDA backing
đź©ą ZEVASKYN achieves greater than 80 percent wound healing in RDEB, now validated in The Lancet
This isn’t just a news recap—it’s your go-to pulse check on the science reshaping tomorrow’s medicine. 🎯
📢 Stay Ahead in Gene and Cell Therapy Research!
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