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 […]
Updated Invectys and CTMC announce FDA clearance of IND application for anti-HLA-G CAR-T cell therapy
HOUSTON, Texas, Dec. 20, 2022 (GLOBE NEWSWIRE) — Invectys, Inc. and CTMC, a joint venture between MD Anderson Cancer Center and National Resilience, Inc., today announced Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for a Phase 1/2a clinical study of IVS-3001, Invectys’s lead engineered human leukocyte antigen A (HLA-G) targeting chimeric antigen […]
IN8bio Announces FDA Clearance to Initiate a Phase 2 Clinical Trial of INB-400 Gamma-Delta T Cells for Glioblastoma
NEW YORK, Dec. 08, 2022 (GLOBE NEWSWIRE) — IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial of a genetically modified […]
I Am ALS and Veterans with ALS send an Open Letter to FDA Requesting an Advisory Committee Meeting to Discuss NurOwn
WASHINGTON, Nov. 23, 2022 /PRNewswire/ — To the Honorable Dr. Robert Califf and Dr. Peter Marks: We represent Veterans with ALS who support Brainstorm Cell Therapeutics’ request for the FDA to hold a public Advisory Committee meeting (“AdCom”) to engage in scientific discourse about the “clinically meaningful” evidence supporting FDA’s approval of a mesenchymal stem cell therapy, NurOwn. When we […]