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 […]
Breakthrough in Alzheimer’s Treatment: Lomecel-B™ Receives RMAT Designation from FDA
Longeveron Inc., a clinical stage regenerative medicine biotechnology company, has achieved a significant milestone in the fight against Alzheimer’s Disease. The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B™ for the treatment of mild Alzheimer’s Disease. This designation underscores the potential of Lomecel-B™ to provide a new […]
Groundbreaking Progress in GvHD Treatment: Tr1X Successfully Doses First Patient in TRX103 Trial
In an exciting development for autoimmune and inflammatory disorders, Tr1X, Inc. has announced the successful dosing of the first patient in its TRX103-01 proof-of-concept trial. This trial is a significant step forward in the fight against Graft versus Host Disease (GvHD), a serious condition affecting patients undergoing mismatched hematopoietic stem cell transplantation (HSCT). TRX103 represents […]
KOSÉ, I Peace, and Reju to Revolutionize Personalized Beauty with iPS Cells
In a groundbreaking move, KOSÉ Corporation, I Peace, Inc., and Reju, Inc. have announced a strategic partnership aimed at developing personalized beauty products using iPS cells. This collaboration brings together the expertise of KOSÉ in beauty products, I Peace’s advancements in iPS cell technology, and Reju’s innovation in iPSF (iPS cell extract) to create customized […]
Senti Bio Receives $8 Million CIRM Grant to Advance Logic-Gated CAR-NK Cell Therapy for AML
Senti Biosciences, Inc., a leader in next-generation cell and gene therapies, has been awarded an $8 million grant by the California Institute for Regenerative Medicine (CIRM). This significant funding will propel the clinical development of SENTI-202, an innovative off-the-shelf CAR-NK cell therapy designed to treat relapsed/refractory hematologic malignancies, including acute myeloid leukemia (AML). Pioneering Cell […]
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 […]
iRegene Receives IND Approval from U.S. FDA to Start Clinical Trial for Parkinson’s Disease
iRegene Therapeutics has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Investigational New Drug (IND) approval for their innovative cell therapy, NouvNeu001, aimed at treating Parkinson’s disease. This approval marks a pivotal step forward in the fight against this debilitating neurodegenerative disorder. A New Hope for Parkinson’s Patients Parkinson’s disease, characterized by the loss of dopaminergic neurons, […]
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 […]