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This marks the second time in two years that Novo has received a Form 483, indicating ongoing concerns

Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This project was funded in part by the Department of Health and Human Services, Health Resources and Services Administration (HRSA), through its grant to the UTMB Center of Excellence for Professional Advancement and Research (grant number 1 D34HP492340100)

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Tirzepatide does not currently come in a pill or tablet form that is FDA-approved

Pricing Pressure Becomes Part of the System If the early GLP-1 era was defined by sticker shock, 2026 marks the point where pricing pressure becomes structural