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…]
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…]
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…]
EU Grants Approval to Zemcelpro, a Cord Blood–Derived Stem Cell Therapy for Blood Cancer Patients
In August 2025, the European Commission (EC) granted conditional marketing authorization (CMA) to Cordex Biologics, a subsidiary of ExCellThera, for Zemcelpro® (UM171 Cell Therapy), a personalized stem cell therapy derived from a single cord blood unit for blood cancer patients who lack access to a suitable donor for a traditional transplant. ExCellThera announced the news on August 27, 2025.
Zemcelpro is the first and only allogeneic cell therapy approved in the EU for this patient population. By leveraging ExCellThera’s proprietary UM171 expansion platform, the therapy enhances the viability and functionality of cord blood stem cells, overcoming a decades-long limitation: insufficient cell volume for adult transplantation. As such, Zemcelpro represents a major clinical milestone and a therapeutic breakthrough with the potential to expand the use of cord blood–derived cellular therapies in the EU and beyond. [Read more…]
Precision Over Hype: Biogenomics’ Genovia Sets a New Standard in Exosome-Based Regenerative Aesthetics
Los Angeles, CA – September 4, 2025 – As industry scrutiny intensifies over cosmetic products making bold but unverified “exosome” claims, Biogenomics, a biotech company advancing regenerative aesthetics, has announced performance breakthroughs for its flagship innovation, Genovia. Unlike competitors who emphasize inflated particle counts, Genovia is engineered through a patented lactoferrin-enhanced process that delivers scientifically validated quality, safety, and functional performance.
“Exosomes aren’t about chasing numbers — they’re about results providers can trust and patients can see,” said a Biogenomics spokesperson. “That’s the standard Genovia delivers.” [Read more…]
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