RMAT FDA

Mesoblast gets FDA RMAT; List of 10 total designations so far

Mesoblast-e1514313188176

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 …

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Reading the tea leaves as new FDA commish Gottlieb blogs on regenerative medicine

Dr.-Scott-Gottlieb

New FDA Commissioner Dr. Scott Gottlieb, M.D., has in the past touched on stem cells and regenerative medicine therapies in speeches or written comments prior to starting his tenure at the agency. Now that he is Commissioner, he is poised to have direct impact on our field rather quickly and potentially with major changes in …

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