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: […]
Vitti Labs Announces FDA Approval of Phase II IND Clinical Trial of Combination Mesenchymal Stem Cell and Exosome Treatment of Pulmonary Fibrosis Secondary to Novel Corona Virus Infection (COVID-19)
LIBERTY, Mo., May 2, 2022 /PRNewswire/ — Vitti Labs, an AATB Accredited Tissue Bank focused on life Science Research, development, and manufacturing, announced today that the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug Application (IND) to move forward with Phase II Outpatient Clinical Trial using a combination of Umbilical Cord […]
FDA Approves Direct Biologics to Proceed with a Landmark Phase 3 Acute Respiratory Distress Syndrome (ARDS) Trial
AUSTIN, Texas, April 26, 2022 /PRNewswire/ — Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced today that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct […]
Seattle Doctor Sued for Marketing Unproven Stem Cell Treatments
A concerned Washingtonian reported US Stemology’s claims to the Attorney General’s Office that it could treat and prevent COVID-19. Apparently the company made these claims for at least three months in the early stages of the pandemic. The Attorney General’s Office sent a cease and desist letter to US Stemology which made them remove the […]