Media Contact:
Stephen Majors
Vice President, Global Communications
smajors@alliancerm.org
Washington, DC
ARM commends the U.S. Food and Drug Administration for its decision to eliminate the Risk Evaluation and Mitigation Strategies (REMS) program and reduce other labeling restrictions for autologous CAR-T cell therapies. This evidence-based decision significantly lowers barriers for physicians administering and patients seeking these transformative treatments.
Washington, DC
ARM is deeply disappointed to learn that Office of Therapeutic Products (OTP) Director Nicole Verdun and Deputy Director Rachael Anatol have been placed on administrative leave. Over the past two years, Nicole and Rachael have modernized the FDA’s regulatory approach to cell and gene therapy (CGT), earning the trust and respect of the CGT community and helping to ensure that the FDA was the global leader in this evolving field.
Boston, MA
The Alliance for Regenerative Medicine (ARM) and the Japanese Society for Regenerative Medicine (JSRM) announce a Memorandum of Understanding to facilitate research, partnerships, and advocacy between enterprises and academic institutions in regenerative medicine and cell and gene therapy.
Washington, DC
Three leading organizations that represent the scientists, academic centers, biotechnology organizations, patients, and service providers closest to the cell and gene therapy field today called for a ten-year global moratorium on heritable human genome editing (HHGE).
