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RSS FeedPosted by Michael Wonder on 14 Nov 2023
Atsena Therapeutics receives FDA regenerative medicine advanced therapy designation for ATSN-101 gene therapy for GUCY2D associated Leber congenital amaurosis
14 November 2023 - ATSN-101 has demonstrated clinically meaningful improvements in vision at the highest dose with no drug-related serious ...
Posted by Michael Wonder on 12 Apr 2022
FDA grants Direct Biologics regenerative medicine advanced therapy designation for the use of ExoFlo in COVID-19 related ARDS
12 April 2022 - Direct Biologics announced that the U.S. FDA has awarded their EV drug product ExoFlo with a regenerative ...
Posted by Michael Wonder on 07 Jun 2021
Innovative regenerative medicine therapies – patient safety comes first
3 June 2021 - The U.S. FDA continues to facilitate the development and availability of innovative medical products, such as regenerative ...
Posted by Michael Wonder on 23 Jul 2020
Potential risks of treatment with unapproved regenerative medicine products
22 July 2020 - Protecting patients is at the core of what we do at the U.S. Food and Drug ...
Posted by Michael Wonder on 17 Jun 2020
Identifying the risks of unproven regenerative medicine therapies
17 June 2020 - In the middle of the coronavirus disease 2019 public health response, many priorities are currently competing for ...
Posted by Michael Wonder on 21 May 2019
Framework for the regulation of regenerative medicine products
21 May 2019 - The U.S. FDA has published four final guidance documents that are part of a comprehensive policy framework ...
Posted by Michael Wonder on 15 Feb 2019
FDA advances new efforts to promote development of safe and effective regenerative medicine products
15 February 2019 - Today, the FDA finalised two guidance documents regarding regenerative medicine therapies. ...
Posted by Michael Wonder on 08 Feb 2018
Rejuvenating regenerative medicine regulation
7 February 2018 - The FDA recently made long-awaited progress toward protecting patients from interventions involving human cell- and tissue-based products ...
Posted by Michael Wonder on 22 Dec 2017
Mesoblast receives FDA regenerative medicine advanced therapy designation for its cell therapy in heart failure patients with left ventricular assist devices
21 December 2017 - Mesoblast today announced that the United States FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ...
Posted by Michael Wonder on 16 Nov 2017
Statement from FDA Commissioner on FDA’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health
16 November 2017 - One of the most promising fields of science is the area of cell-based therapies and their ...
Posted by Michael Wonder on 16 Nov 2017
FDA announces comprehensive regenerative medicine policy framework
16 November 2017 - Framework aims to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy. ...