RFK isn’t even confirmed as HHS Secretary and things are going south already with an NIH freeze. What do I mean? NIH freeze could do lasting damage to biomedical research The Trump Administration has frozen many NIH processes including meetings such as study sections that evaluate grant proposals. No study sections means almost no new […]
What are the current FDA-approved cell and gene therapies? How many of those involve true stem cells? Many of us have wished for a more specific list of FDA-approved stem cell therapies. Patients and fellow scientists often asked me about such lists. They even wish for annotated lists. For that reason, I’ve made and kept
Updated 2025 List of FDA-Approved Cell and Gene Therapies Read More »
How will things change at the FDA under the second Trump Administration? It’s a key question for our field but not easy to answer. Most likely there will be more instability at the agency. Some leaders, like of CDER, have already left. in my overall regenerative medicine predictions for 2025, I’ve included more predictions about
Weekly reads: FDA modernization, TFs on the brain, mortality timer, pluripotent trials Read More »
The U.S. Supreme Court could soon have a historic opportunity to limit the scope of FDA stem cell oversight. A large stem cell clinic firm now says it plans to ask SCOTUS to review a case it recently lost on appeal to the FDA. If SCOTUS takes the case, the FDA could find its powers
FDA stem cell oversight at risk as clinics to ask SCOTUS to weigh in Read More »
In a landmark decision, today the FDA approved Ryoncil from Mesoblast for GvHD. This is the first time the FDA has approved a mescenchymal stromal/stem cell or MSC therapy of any kind. There have been many ups and downs for Mesoblast toward this approval of Ryoncil or remestemcel-L, an allogeneic marrow MSC product. See my
In landmark, FDA approves first MSC therapy, Mesoblast’s Ryoncil for GvHD Read More »
The FDA recently warned Frontier Biologics, LLC, a Texas perinatal tissue manufacturer firm. Tallying the many FDA biologics warnings in 2024 It can sometimes feel like there are an uncountable number of unproven stem cell clinics However, the good news is that the FDA has been doing much more on this front in 2024. With
FDA warns Frontier Biologics as part of its more active trend Read More »
How might Trump’s nominee to lead the FDA, Martin Makary, change the agency? Should we be worried or hopeful? I’ve been closely following the FDA and its commissioners ever since I started The Niche in 2010. I’ve been particularly interested in how these leaders impacted FDA actions on cell and gene therapies. How might Makaray
What you need to know about Martin Makary and planning for the Trump 2.0 FDA Read More »
It’s been a long saga for the FDA and the unproven stem cell clinic group called Cell Surgical Network, headquartered in Beverly Hills. A court case involving the two has been unfolding for many years. It has big implications for agency authority and the hundreds of stem cell clinics across the U.S. The case took
The cell therapy biotech Capricor recently released new data from their Duchenne Muscular Dystrophy (DMD) trial work. The data have generated excitement in the patient advocacy community. The stock has skyrocketed. How exciting are these new data? CEO Linda Marbán is quite upbeat and I think it’s justified. The firm is now seeking FDA approval
Capricor seeks FDA approval of deramiocel for Duchenne based on encouraging data Read More »
It’s Halloween and one of the scariest things out there is a wild tweet from RFK Jr on stem cells and the FDA. Why worry what Kennedy thinks about such topics? Trump has indicated that Kennedy will have some major healthcare role in his second term should he be re-elected. The last thing we need
RFK Jr on stem cells & his wacky war on the FDA Read More »