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DOI: 10.1158/0008-5472.CAN-04-2253

In support of these claims, the applicant provided two retrospective reviews (Lee et al., 2022 and Muscarella, 2022) of medical device reports (MDRs) from the FDA Manufacturer and User Facility Device Experience (MAUDE) database, an FDA News Release (2021, April 1) concerning infection and contamination risks associated with reusable urological endoscopes, and an FDA Update (2025, January 31) communicating the recall of endoscope accessories from Olympus reusable urological endoscopes as supporting evidence

1 This ground-breaking study showed that the gene therapy cell product (betibeglogene autotemcel or beti-cel) led to transfusion independence in most treated patients (16/18, 89%), all of whom had genotypes that are associated with severe -thalassemia (i.e., 0 / 0 , 0 / IVS1-110 , IVS1-110 / IVS1-110 )

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(2022, May 15)