by Kevin Robb | May 22, 2025
For the first time, mesenchymal stromal cells (MSCs) can be used in routine clinical practice under the nod of regulatory approval in the United States. The MSC product known as Ryoncil was made available to patients in March 2025 following a historic decision from...
by Laya Kiani | Mar 6, 2025
The biotechnology sector has always been a hub of innovation, consistently pushing the boundaries of scientific and technological advancements. However, transforming novel discoveries into viable market-ready solutions requires substantial financial backing. Among the...
by Stacey Johnson | Jan 31, 2025
In a new location, with highways replacing waterways, it’s comforting to have an agenda with some consistent touchpoints for familiarity, and Advanced Therapies Week 2025 (ATW25), January 20-23 in Dallas, Texas, began with two of my favourites: the Super plenary,...
by Anis Fahandej-Sadi | Dec 5, 2024
If you’re reading this, you’re probably aware of the massive strides the cell and gene therapy (CGT) industry has made in the last few years. Between 2017 and 2022, six CGT products were approved by the U.S. Food and Drug Administration, but we saw eight approvals in...
by Kevin Robb | Aug 22, 2024
Last month, the U.S. Food and Drug Administration (FDA) agreed to formally review a revised Biologics License Application (BLA) from Mesoblast for their mesenchymal stromal cell (MSC) product, remestemcel-L. The submission represents the third attempt by the company...
by Laya Kiani | Jul 18, 2024
In last week’s post, “The role and impact of IP rights on innovation and investment in RM,” I discussed the importance of intellectual property (IP) rights in regenerative medicine (RM), highlighting how they drive innovation and secure competitive advantages....
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