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Currently available biomarkers do not outperform serum ALT in identifying patients with NASH, which has poor sensitivity ( 3) and any amount of fibrosis, focus has shifted toward trials with fibrosis as the primary indicator of efficacy, as fibrosis is the histologic feature of NASH most clearly linked to risk of decompensation or liver-related events

A temporary policy could arrive sooner than a completed rule, while notice-and-comment rulemaking can take months or longer

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The center also reported a small but growing number of calls involving retatrutide, an investigational triple agonist that is not FDA approved but is sold online as a research chemical not intended for human consumption