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 »
Australian biotech Mesoblast has had a rollercoaster ride working toward FDA approval of its mesenchymal cell therapy product remestemcel-L. They are seeking approval for use in patients with graft-versus-host disease (GvHD). More specifically, it is intended for pediatric patients with steroid-refractory acute graft versus host disease, or SR-aGVHD. This is a serious condition and new treatment
Hoping for approval, Mesoblast says FDA wants new remestemcel-L trial Read More »
It’s great when an idea like stem cells for osteoporosis just makes so much common sense, but it still requires data. A logical hypothesis is not enough. The point of today’s post is to fact-check the idea of using stem cells for such bone loss. A femur to stand on? Unfortunately, the take-home message is
Boning up on stem cells for osteoporosis: good idea, little data so far Read More »