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 […]
BrainStorm Cell Therapeutics Advances ALS Treatment with Phase 3b Trial of NurOwn®
In a significant stride towards combating neurodegenerative diseases, BrainStorm Cell Therapeutics Inc. has announced its submission of a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3b study of NurOwn®, its pioneering investigational treatment for amyotrophic lateral sclerosis (ALS). This move, following a constructive in-person meeting with […]
BrainStorm Cell Therapeutics Announces Key FDA Meeting for ALS Treatment
BrainStorm Cell Therapeutics Inc., a prominent developer of adult stem cell therapies for neurodegenerative diseases, has announced a significant development in their pursuit of treating amyotrophic lateral sclerosis (ALS). The company has secured an in-person meeting with the U.S. Food & Drug Administration (FDA), scheduled for December 6, 2023. This meeting is a critical step […]
BioCardia Announces FDA Approval for Groundbreaking Heart Failure Treatment
BioCardia, Inc., a prominent player in the development of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has recently announced a significant milestone. The U.S. Food and Drug Administration (FDA) has approved the Phase III clinical trial protocol for BioCardia’s CardiAMP autologous cell therapy. This therapy is designed for patients suffering from ischemic heart […]
FDA Grants Fast Track Designation to ANPD001 for Parkinson’s Disease Treatment
Aspen Neuroscience, a clinical development-stage company, recently announced a significant milestone in the fight against Parkinson’s disease (PD). The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ANPD001, an autologous (personalized) investigational cell therapy designed to treat Parkinson’s disease by replacing lost dopamine neurons. This designation aims to accelerate the development […]
Orchard Therapeutics Moves Closer to a Breakthrough Treatment for MLD
Orchard Therapeutics, a global leader in gene therapy, has recently made significant strides in the development of a treatment for metachromatic leukodystrophy (MLD). Here’s a detailed summary of the press release: Key Developments: Insights from Orchard Therapeutics: Bobby Gaspar, M.D., Ph.D., co-founder and CEO of Orchard Therapeutics, expressed the company’s commitment to addressing the urgent […]
Aspen’s Breakthrough FDA-Cleared Parkinson’s Cell Therapy Unveiled
Aspen Neuroscience has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ANPD001, an autologous cell therapy designed to treat Parkinson’s Disease (PD) by replacing lost dopamine neurons. The clearance enables Aspen to initiate a first-in-patient Phase 1/2a clinical trial for individuals with moderate to severe […]
BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review Biologics License Application for NurOwn® for the Treatment of ALS
NEW YORK, March 27, 2023 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) will hold an Advisory Committee Meeting (‘ADCOM’) to discuss the company’s Biologics License Application (BLA) for NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). Given the […]