SHANGHAI, June 23, 2026 — UniXell Biotechnology Co., Ltd. (“UniXell”) has secured Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for UX-DA003, its allogeneic induced pluripotent stem cell (iPSC)-derived therapy for Parkinson’s disease. Paired with the prior IND approval from China’s National Medical Products Administration (NMPA) on June 3, 2026, the candidate will undergo clinical development in both China and the United States concurrently, marking a landmark dual-country breakthrough for the company’s neurodegenerative disease pipeline. This milestone solidifies UniXell’s unique dual-pathway clinical strategy covering personalized autologous and scalable off-the-shelf allogeneic iPSC therapeutics.
Pluristyx and Qkine Announce a Reciprocal Distribution Agreement in Support of Optimized Growth Factor Differentiation of Induced Pluripotent Stem Cell (iPSC)
SEATTLE, WA and CAMBRIDGE, UK — Pluristyx, a leading provider of clinical-grade induced pluripotent stem cell (iPSC) solutions, and Qkine, a pioneer in the manufacture of high-purity, animal-free growth factors and cytokines, today announced a distribution agreement to support streamlined and efficient R&D and manufacturing of differentiated cells and tissues from iPSC. This collaboration will provide researchers, product manufacturers, and therapeutic developers with a streamlined, high-performance workflow, pre-qualified to deliver reliable differentiation of iPSCs into product cells and tissues. [Read more…]
UCB’s $1.15 Billion Bet on Neurona Signals Major Push into Pluripotent Stem Cell–Derived Cell Therapy
In one of the largest regenerative medicine deals of 2026 to date, UCB has announced plans to acquire Neurona Therapeutics in a transaction valued at an astounding price tag: up to $1.15 billion. The deal includes $650 million upfront, with an additional $500 million tied to future milestones, underscoring the scale of UCB’s commitment to next-generation therapeutic modalities. [Read more…]
Cell-Easy Launches an iPSC-Derived Beta Cell Program to Tackle Scale-Up Challenges
Backed by a €12M Bpifrance grant, the program builds a GMP-compatible manufacturing platform for iPSC-derived cell therapies — directly applicable to biotech and pharma iPSC programs.
Toulouse, 2026 April 16th – Scale-up remains one of the most critical unsolved challenges in iPSC-derived cell therapy. Despite strong clinical promise, most manufacturing processes today can only supply material for a very limited number of patients — a bottleneck that limits clinical progression and commercial viability across the field. [Read more…]
iPSC Therapies Make History: Japan Authorizes World’s First Two iPSC-based Cell Therapies
Recently, the world witnessed the approval of the world’s first two iPSC-derived medicines, as Japan’s health ministry panel authorized their commercialization on February 19, 2026. The approved therapies are ReHeart, developed by Cuorips Inc., a regenerative medicine company spun out of research at Osaka University, and Amchepry, developed by Sumitomo Pharma Co., Ltd. in collaboration with Racthera Inc. [Read more…]
- 1
- 2
- 3
- …
- 18
- Next Page »