Thursday, November 30, 2017 10:35:59 AM
Consumers Capitalize on Advanc-es in Science (posted July 7, 2017), https://blogs.fda.gov/fdavoice/index.php/2017/07/how-fda-plans-to-help-consumers-capitalize-on-advances-in-science/; Humacyte Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Expedited Review Designation for HUMACYL® in Vas-cular Access for Hemodialysis (March 20, 2017), http://www.humacyte.com/press/humacyte-receives-fda-regen-erative-medicine-advanced-thera-py-rmat-expedited-review-designa-tion-humacyl-vascular-access-hemo-dialysis/; Enzyvant Receives FDA Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation for Investi-gational Therapy RVT-802 (April 17, 2017), http://www.prnewswire.com/news-releases/enzyvant-re-ceives-fda-breakthrough-therapy-desig-nation-and-regenerative-medicine-ad-vanced-therapy-designation-for-inves-tigational-therapy-rvt-802-300440401.html?tc=eml_cleartime; jCyte Receives Regenerative Medicine Advanced Ther-apy Designation (May 2, 2017), http://jcyte.com/2017/05/jcyte-receives-re-generative-medicine-advanced-thera-py-designation/; Vericel Receives FDA Regenerative Medicine Advanced Ther-apy (RMAT) Designation for Ixmye-locel-T for the Treatment of Advanced Heart Failure Due to Ischemic Dilated Cardiomyopathy (May 10, 2017), http://investors.vcel.com/releasedetail.cfm?re-leaseid=1025739.
Note 13.
https://www.google.com/url?sa=t&source=web&cd=7&ved=0ahUKEwjs5PaQzebXAhXhzFQKHY_qB9AQFggcMAY&url=http%3A%2F%2Fwww.bipc.com%2Fassets%2FPDFs%2FNews-Events%2FFDA%2520Sharpens%2520its%2520Focus%2520on%2520Regenerative%2520Medicine%2520Regulation%2520-%2520Barbara%2520Binzak%2520Blumenfeld.pdf&usg=AOvVaw111zOOY4vYpDkkEDvtyf1J
Four approvals and 11 meet the criteria. Not as current as Eagle’s, but as of September.
Recent NWBO News
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