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This shifts the narrative from "weight loss" to "medical necessity." Submit Your Appeal You typically have 180 days (six months) from the denial date to file an appeal

Worryingly, based on the language of the release, it seems FDA doesnt quite understand how compounders actually acquire their APIs

2 Reports of adverse events associated with compounded semaglutide and tirzepatide have surfaced, ranging from gastrointestinal side effects to overdosing, injection site reactions, and even hospitalization

Gut Health Emerges as Massive Market For many consumers, the quest for good gut health has just begun and businesses are ready like Viome, a healthtech and longevity startup that raised $87 million for its at-home microbiome testing kit

doi:10.1001/JAMAONCOL.2025.2681 Zhao X, Wang M, Wen Z, et al

January 17th, 2025: Study reveals most compounded GLP-1 websites fail to disclose FDA status and safety risks A recent study has highlighted concerns about websites selling compounded versions of popular weight-loss medications, including Novo Nordisks Wegovy and Eli Lillys Zepbound, often without disclosing important safety information