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BioMarin Announces RMAT Designation Granted to Valoctocogene Roxaparvovec for Hemophilia A americanpharmaceuticalreview
March 11, 2021
BioMarin Pharmaceutical announced the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe ...
Orchard Therapeutics Announces OTL-200 Granted RMAT Designation americanpharmaceuticalreview
January 21, 2021
Orchard Therapeutics announced the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to OTL-200, an investigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy for the ...
Novartis’ Kymriah Gets RMAT Designation contractpharma
April 23, 2020
Investigational new indication to treat patients with relapsed or refractory follicular lymphoma.
FDA grants RMAT designation to SanBio’s cell therapy pharmaceutical-technology
September 25, 2019
The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to SanBio Group’s cell therapy, SB623, to treat chronic neurological motor deficits secondary ...
FDA Grants RMAT Designation to AT132 americanpharmaceuticalreview
August 22, 2018
Audentes announced the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to AT132 for the treatment of X-linked Myotubular Myopathy (XLMTM).