FDA Accepts BLA for Ryoncil: First Allogeneic “Off-the-Shelf” Cellular Medicine and First Cell Therapy for Children in the United States
In a significant milestone for pediatric medicine, the FDA has accepted Mesoblast’s Biologics License Application (BLA) for Ryoncil® (remestemcel-L), aimed at treating children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD). This acceptance marks a crucial step towards the approval of the first allogeneic “off-the-shelf” cellular medicine in the United States, and the first cell therapy for […]
Breakthrough in Muscular Dystrophy Treatment: FDA Approves Stem Cell Therapy from Myogenica
The fight against muscular dystrophy has taken a promising turn with the recent FDA approval of an Investigational New Drug (IND) application for MyoPAXon, a revolutionary stem cell-derived muscle stem cell product developed by Myogenica, a University of Minnesota startup. This landmark approval paves the way for a clinical trial aimed at treating patients with […]
Revolutionary Stem Cell Treatment for Hair Loss: Eirion Therapeutics Leads the Way
Eirion Therapeutics, a pioneer in stem cell research, has announced the commencement of a groundbreaking Phase 1 clinical trial to evaluate the safety of ET-02, a topical pharmaceutical designed to treat androgenic alopecia, commonly known as age-related hair loss. This double-blind, placebo-controlled study marks a significant milestone in the treatment of hair loss, enrolling the […]
BrainStorm Cell Therapeutics Aligns with FDA on Phase 3b NurOwn Clinical Trial CMC Aspects
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, has reached an important milestone by aligning with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of its Phase 3b clinical trial for NurOwn®, an investigational therapy for amyotrophic lateral sclerosis (ALS). This […]
Controversial Utah Bill Threatens FDA’s Authority Over Stem Cell Therapies
In a concerning development for the field of stem cell research and therapy, the International Society for Cell & Gene Therapy (ISCT) has voiced its opposition to a proposed bill in Utah that could undermine the U.S. Food and Drug Administration’s (FDA) ability to regulate stem cell products and protect patient safety. The bill, known as the “Right to […]
Unleashing the Power of Stem Cells: STEMREGEN® Launches Three Innovative Supplements at Biohacking Conference
In a groundbreaking announcement at the Biohacking Conference in Dallas, Texas, STEMREGEN® unveiled three new stem cell-boosting supplements designed to enhance the body’s natural repair system. As the pioneer in stem cell science-backed supplements, STEMREGEN® continues to lead the way with innovative products that support healthy aging and athletic recovery. STEMREGEN® Release: Enhancing Innate Repair […]
REPROCELL USA Launches Advanced GMP Facility for Stem Cell Manufacturing
REPROCELL USA has marked a significant milestone with the inauguration of its state-of-the-art GMP manufacturing facility dedicated to producing high-quality stem cells. This facility, located in Beltsville, Maryland, was officially opened on May 15, 2024, by Mr. Kevin Anderson, Secretary of the Department of Commerce, State of Maryland. The new facility is designed to manufacture […]
New York Blood Center Expands GMP Cell & Gene Therapy Manufacturing in Louisville
New York Blood Center Enterprises (NYBCe) has announced the grand opening of its new GMP facility in Louisville, Kentucky. This state-of-the-art site, part of Comprehensive Cell Solutions (CCS), enhances cell and gene therapy manufacturing capabilities, offering end-to-end services from cell sourcing to cryopreservation and GMP manufacturing. The Louisville facility includes apheresis suites, cleanrooms, and quality […]
Immorta Bio Inc. Announces Breakthrough in Liver Failure Treatment with Stem Cell Technology
Immorta Bio Inc., a company focused on longevity and regenerative medicine, has announced a significant breakthrough in the treatment of liver failure. The company is developing personalized stem cell technologies that show great promise in combating various diseases of aging. Immorta Bio’s research pipeline includes Personalized Regenerative Cells (PRCs), Personalized Mesenchymal Stem Cells (pMSCs), and […]
Theradaptive Secures Landmark Funding to Propel Human Clinical Trials in Stem Cell Research
In a groundbreaking development for stem cell research and regenerative medicine, Theradaptive has secured significant funding from the Maryland Stem Cell Research Fund (MSCRF). This crucial financial boost will support the advancement of their innovative human clinical trials, marking a significant milestone in the field of biotechnology. Theradaptive, a pioneering biopharmaceutical company, is renowned for […]