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Diabetic Medicine, 21(2), 114-121

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Comment: With respect to the newness criterion at 419.66(b)(1), the applicant reiterated that the VersaVue TM Single-Use Flexible Cystoscope received 510(k) clearance from FDA on October 6, 2023, and that it submitted an application for pass-through status on February 11, 2025, which is within 3 years of the initial market authorization

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Pitolisant in PWS is currently advancing through late-stage development, with Phase III topline data readout expected in 2H 2026

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