Search Results for: fda

Weekly reads: Altos Labs aging supplements pub, destructive NIH cuts, FDA warning, HSCs

Steve Horvath, Altos Labs

When I think of so-called aging supplements, visions of snake oil dance in my head. Possible benefits of supplements more generally have mostly not held up to long-term research. Supplements have risks too and so do purported longevity supplements. These pills claiming to fight aging are more in the realm of stem cell supplements that […]

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FDA letters to Chara Biologics & Evolutionary Biologics continue its unprecedented slew of warnings

Dr. Joy Kong, Chara Biologics, Chara Health

What is Chara Biologics? Why did the FDA just warn them and another firm? FDA’s CBER keeps up fast pace of warnings Before we get into that, the FDA biologics branch, CBER, has more generally kept up an unprecedented pace of warning letters over the past 13 months. I wrote late last year how 2024

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NAE member Mary Pat Moyer on FDA Warning Letter to her firm INCELL Corporation

A Texas firm called INCELL Corporation has received an FDA warning letter about an amniotic product it manufactures. The letter was addressed to the firm’s founder and leader Dr. Mary Pat Moyer. The letter is somewhat unusual as Dr. Moyer is the Chief Science Officer of INCELL, and is an academic scientist with over 250

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Weekly reads: NIH freeze even before RFK confirmation, FDA warnings, RP stem cell trial data

NIH freeze

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

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Updated 2025 List of FDA-Approved Cell and Gene Therapies

FDA

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

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Weekly reads: FDA modernization, TFs on the brain, mortality timer, pluripotent trials

FDA

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

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FDA stem cell oversight at risk as clinics to ask SCOTUS to weigh in

FDA stem cell oversight

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

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In landmark, FDA approves first MSC therapy, Mesoblast’s Ryoncil for GvHD

mesoblast ceo dr silvio itescu

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

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FDA warns Frontier Biologics as part of its more active trend

Chad W. Justice, Frontier Biologics

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

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What you need to know about Martin Makary and planning for the Trump 2.0 FDA

Martin Makary, Trump FDA

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

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