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112 However, in recent years, the FDA has introduced the patient-focused drug development initiative, where patient-reported outcomes such as improvements in quality of life and healthy life years in MASH patients following treatment can serve as trial endpoints, potentially influencing final approval based on these data

[2] Medvi Review After 10 Months of Use Better Than I Expected

In June, the European Medicines Agencys PRAC identified NAION as a very rare adverse event linked to semaglutide and recommended updating product labels with vision warnings

Understanding this timeline helps set realistic expectations