Latest Regenerative Regulatory News

Ensoma nabs IND from the FDA for first in-vivo HSC-directed gene insertion therapy

With FDA approval secured, Ensoma prepares to advance its groundbreaking in vivo therapy into clinical trials targeting X-CGD patients.

FDA approves IV adipose stem cell trial for Crohn’s disease, a Phase 2b from L2 Bio

What appears to be a small stem cell banking company is working on expanded adipose stem cell therapy for various autoimmune conditions.

Hematopoietic Stem Cell-Directed Gene Insertion Therapy Gets IND Clearance

With FDA clearance secured, Ensoma prepares to launch its Phase 1/2 clinical trial to establish safety, efficacy, and dosing.

Applied StemCell Submits iPSC Drug Master File to the FDA

This milestone may bring us closer to regulatory-ready iPSCs.

FDA approves new nerve repair product from Orthocell

With FDA approval now secured, Orthocell prepares to launch Remplir into the lucrative US nerve repair market, accelerating commercialisation.

Chinese stem cell (iPSC) therapies receive Phase I trial clearance for ALS & Parkinson’s

They'll be using allogeneic iPSCs to treat neurodegenerative disorders. ALS stem cells can be a tough topic after the Nurown trials... are iPSCs the answer?

First FDA-approved stem cell therapy, Ryoncil, now available. Medicaid coverage coming soon

A significant milestone for the stem cell industry, likely paving the way for future stem cell based therapies.

Pharmaceutical giant GSK sees stem cells as useful for drug discovery and therapeutics

Florida Republicans introduce two bills to allow umbilical stem cell therapy: Here’s what you should know

Celularity gets 361 nod from FDA for its amniotic derived wound care products, Natalin and Acelagraft™ 

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