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Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1)

FDA asked Medline Industries to respond to its warning letter within 15 business days and noted that since the December 2025 inspection, the agency has updated its Quality System (QS) regulation to the Quality Management System Regulation (QMSR) to harmonize with international regulatory standards

Through this review, we expect to have an encouraging opportunity to develop NPTAs to achieve efficient treatment of AD and further promote its clinical translation