Tag Archive for: US Food and Drug Administration

Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation

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At 12 months, mean eGFR was 51.5 mL/min/1.73m2 in the imlifidase arm versus 19.3 mL/min/1.73m2 in the control arm with a statistically significant and clinically meaningful difference of 32.2 mL/min/1.73m2 ( p<0.0001) Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience Submission of a Biologic License Application (BLA) under accelerated approval pathway […]

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Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXessTM, its restorative vascular access conduit

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aXess is a restorative arteriovenous dialysis conduit which allows vascular access for hemodialysis through the creation of a new, permanent, living vessel EINDHOVEN, The Netherlands, 13 June 2024 – Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has gained approval from the US […]

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