Stem cell stocks, meaning cellular therapy biotech companies, face many challenges, but their clinical research is crucial. Stem cell biotechs These biotechs have ups and downs, sometimes at the same time. This is kind of the standard of “life” as any biotech company. It is definitely the case in the volatile stem cell and cell …
24 cell therapy & stem cell stocks I’m following Read More »
There is always plenty of complicated, mixed-bag news on the stem cell and regenerative medicine front so it’s great to highlight when there’s some good news out there. Today’s post includes several such upbeat items. At the bottom I’ve included a list of some recent interesting publications as well. Good news on vision front: jCyte …
Stem cell & regenerative medicine good news & pubs Read More »
This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm …
FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36 Read More »
Today’s post includes a list of firms/products that have self-reported that they have received FDA regenerative medicine advanced therapy designation or RMAT. Sometimes people call these “r mat” with a space. As of December 12, 2023 there are 85 RMATs in the public domain. I also include FDA data on RMAT submissions via an FDA RMAT resource …
Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting …
Mesoblast gets FDA RMAT; List of 10 total designations so far Read More »
The 21st Century Cures Act has some important regenerative medicine language in it. One part of that was attempting to accelerate FDA review of promising investigation regenerative medicine therapies. The mechanism for this was a new designation called Regenerative Advanced Therapy, now renamed Regenerative Medicine Advanced Therapy (RMAT) Designation. I don’t think anyone was sure …
Big change for stem cell field with FDA quickly issuing RMATs Read More »
Recently I was at the World Alliance Forum in San Francisco (WAFSF), a great meeting on stem cells and regenerative medicine. WAFSF had some excellent talks and I saw one session on the use of stem cells to treat vision impairment that was particularly striking. World Alliance Forum in San Francisco (WAFSF) This session’s all-star lineup included Drs. David …
WAFSF stem cell vision talks: Hinton, Tsukamoto, Klassen, Takahashi Read More »