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Arnbak et al
CagriSema submitted for FDA approval in December 2025 with expected approval in Q4 2026 or Q1 2027, meaning launch around mid-2027
We stated in the CY 2026 OPPS/ASC proposed rule that, first, the evidence provided did not include data demonstrating that the use of the VersaVue [TM] Single-Use Flexible Cystoscope compared to other available single-use, disposable cystoscopes for this patient population results in substantial clinical improvement
The logic behind this combination is straightforward
Journal of Translational Medicine
And the landmark 2014 paper that established how dihexa was supposed to work in the brain was retracted by the journal in 2025
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