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 […]
BrainStorm Cell Therapeutics Receives Refusal to File Letter from FDA for its New Biologics License Application for NurOwn for the treatment of ALS
NEW YORK, Nov. 10, 2022 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that the company has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) regarding the company’s New Biologics License Application (BLA) for NurOwn for the treatment of ALS. The […]
Perinatal Stem Cell Society Calls Emergency Session to Garner Industry Support for FDA
FORT LAUDERDALE, Fla., Oct. 26, 2022 /PRNewswire/ — The Perinatal Stem Cell Society has organized a workshop Nov. 3 in Fort Lauderdale, Fla. and streamed to unite the biologics industry and work with the FDA towards a patient-centered goal. “I called this one-day workshop so the industry can partner with the Food and Drug Administration to find solutions that will enable […]
FDA Loses Stem Cell Therapy Lawsuit
Dr. Bill Johnson of Innovations Medical in Texas explains the decision the FDA made in 2018 regarding stem cells and how it restricted their use in the United States. Watch this short video for the good news regarding the ruling that the Federal Court recently made. Video Transcript: Hi. I’m Dr Bill Johnson of Innovations […]
Regenerative Medicine Treatment Options
In this webinar replay, Dr. Siddharth Tambar from Chicago Arthritis and Regenerative Medicine reviews regenerative treatment options in details and answers audience questions. Video Transcript: Hello, everyone – this is Siddharth Tambar from Chicago Arthritis and Regenerative Medicine. Welcome to our webinar today on regenerative medicine treatments. As I’m talking, I’ve got a little bit […]
California Judge Sides with Stem Cell Clinic Against the FDA
The Honorable Jesus Bernal (federal judge in Riverside), has issued his judgement in the United States of America Versus The California Stem Cell Treatment Center. Judge Bernal’s ruling has declared that the stem cells from your own fat are not a drug and the FDA was functioning outside its jurisdiction. Judge Bernal accepted that The […]
How Regenerative Medicine & Stem Cell Therapy Impacts Aging
Lance Hitchings has an excellent YouTube channel where he shares everything he has learned on his quest to turn back the hands of time when it comes to aging. In the following video, Lance gives an update on what regenerative medicine and stem cell therapies are currently doing in the field of aging. Video Transcript: […]