FDA Grants Kochi E. Bio053 Regenerative Medicine Advanced Therapy Qualifications
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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today, Cozie Bio announced that the U.SFood
and Drug(http://Administration (
FDA(http://) has granted
its(http://CT053 Regenerative Medicine Advanced Therapy (RMAT) for the treatment of recurrent/difficult multiple myelomaAbout CT053
CT053 is an all-human anti-BCMA chimeric antigen receptor-modified T-cell (CAR-T), currently in China's registered clinicaltrial(http://has been carried out in Beijing Chaoyang Hospital, Suzhou University hospital, and will be launched in more than 10 clinical research centers;'s eligibility for RMAT is based on the results of exploratory clinical studies conducted by Kozy Bio in China and is another important regulatory milestone following the fda's designation as Orphan Drug and the inclusion of the European Medicines Regulatory Agency (EMA) in the priorityDrug(http://(PRIME) programCT053 The latest follow-up results will be reported at the 61st Annual American Blood Conference (ASH) on December 9, 2019
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