New RMAT Designations Include Autolous’ CAR-T, Direct Biologics’ Extracellular Vesicles And Allovir’s Antiviral T-cells
Latest regenerative medicine advanced therapy awards from US FDA address B-cell acute lymphocytic leukemia, acute respiratory distress syndrome associated with COVID-19, infection risk in stem cell transplant patients, and an ultra-rare form of severe combined immunodeficiency.
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AlloVir Gains Third RMAT Designation For Antiviral T Cell Therapy
Gaining the special regulatory status in a prophylactic setting for posoleucel is the most significant yet for the T cell therapy developer.
US FDA Grants RMAT Requests At Similar Rate To Breakthrough Designations
Over the first five years of the regenerative medicine advanced therapy designation, analysis by the Pink Sheet finds the 40% success rate of requests is comparable to the broader breakthrough therapy designation, despite less stringent RMAT criteria.
Autolus On The Rise After Big Backing From Blackstone
The cash injection comes as a potentially pivotal trial of Autolus's next-generation leukemia CAR-T therapy continues to enrol ahead of a readout in 2022.