Sept 8, 2025, Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to announce the release of the first edition of Cell and Gene Therapy Standards for Pharmacy, which take effect Oct. 1, 2025, and are now available for purchase on the AABB Store. These new Standards represent a critical advancement in strengthening quality and safety for cell and gene therapy (CGT) products managed by pharmacies. [Read more…]
Stem Cell News
BioInformant's coverage of stem cell news includes iPS cells, mesenchymal stem cells, hematopoietic stem cells, neural stem cells and more.
As the first and only market research firm to specialize in stem cell news, BioInformant research has been cited by the Wall Street Journal, Xconomy, AABB, and Vogue Magazine.
Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs, BioInformant is your global leader in stem cell industry news.
Cartherics Wins ‘Most Promising iPSC Therapy Pipeline in APAC’ at Asia Pacific Cell & Gene Therapy Excellence Awards
Melbourne, Australia, 11 September 2025 – Cartherics Pty Ltd (“Cartherics” or “Company”), a biotechnology company developing off-the-shelf immune cell therapies focusing on high-impact women’s diseases, with lead programs in ovarian cancer and endometriosis, is proud to announce that it has been named ‘Most Promising iPSC Therapy Pipeline in APAC’ in the Asia Pacific Cell & Gene Therapy Excellence Awards 2025 (APCGTEA 2025). [Read more…]
European Commission Grants First Approval for Expanded Cord Blood Stem Cell Therapy (Zemcelpro®)
September 10, 2025 — In a landmark move for regenerative medicine, the European Commission has conditionally authorized Zemcelpro®, the first treatment in Europe to use expanded umbilical cord blood stem cells. Developed by Canadian biotech company ExCellThera, this therapy is only the second of its kind approved worldwide and represents a major advance in transplant options for patients with blood cancers such as leukemias and myelodysplastic syndromes. [Read more…]
Congress Moves to Reauthorize Funding for National Cord Blood and Bone Marrow Transplant Programs
Legislation would authorize $280 million over 5 years to support National Cord Blood and Bone Marrow Transplant Programs.
A bipartisan group of lawmakers in the U.S. House has introduced new legislation to extend funding for two cornerstone programs that connect patients with life-saving stem cell treatments. The Stem Cell Therapeutic and Research Reauthorization Act of 2025 proposes more than $280 million in federal funding over the next five years, ensuring that these initiatives continue past their current 2026 expiration date. [Read more…]
Regenerelle® Issues Response to FDA Untitled Letter
Rochester, NY — September 8, 2025 — Regenerelle®, a global leader in the manufacturing and distribution of Wharton’s Jelly Mesenchymal Stromal Cells (WJ-MSCs) and exosomes derived from WJ-MSCs, today announced the public release of its full response to the U.S. Food and Drug Administration (FDA) Untitled Letter dated May 22, 2023.
The disclosure is being made by AT Venture Center, the parent company of Regenerelle, LLC, the regenerative biotherapeutic manufacturing and distribution arm of the company providing stem cells and exosome products to its subsidiaries and distributors serving an extensive connected network of more than 4,000 regenerative medicine and aesthetics professionals worldwide, including MedSpas, orthopedic and pain clinics, wound care centers, and aesthetic practices. [Read more…]
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