Bayer Contrast Agent New Drug Application Accepted for FDA Review

tim.hodson

Wed, 08/27/2025 – 10:29

Aug. 27, 2025 — Bayer has announced that a New Drug Application (NDA) for its investigational contrast agent gadoquatrane has been accepted for review by the U.S. Food and Drug Administration (FDA). The NDA for gadoquatrane has been filed for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and pediatric patients, including neonates.
If approved, gadoquatrane would become the lowest dose macrocyclic gadolini…

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