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(2022, May 15)

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

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

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 )

A B12 shot is a quick intramuscular injection of vitamin B12 (cobalamin) that bypasses the stomach acid, liver metabolism, and intestinal absorption issues that limit oral B12 to roughly 1% bioavailability in most adults