Bayer (BAYRY) announced that a new drug application for its investigational contrast agent gadoquatrane has been accepted for review by the FDA. The NDA for gadoquatrane has been filed for contrast-enhanced magnetic resonance imaging of the central nervous system and other body regions in adults and pediatric patients including neonates. If approved, gadoquatrane would become the lowest dose macrocyclic gadolinium-based contrast agent available in the U.S. The submitted dose is 0.04 mmol gadolinium per kilogram body weight, corresponding to a 60% reduction compared to macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on BAYRY:
- Bayer AG’s New Pediatric Study: A Closer Look at Rivaroxaban for VTE
- Bayer AG’s Promising Phase 3 Study on Prostate Cancer Treatment
- Bayer’s New Clinical Study on HER2-Targeted Cancer Treatment: A Potential Game Changer
- Bayer AG’s Exploratory Study on Sepsis and DIC: A Potential Game Changer?
- Bayer AG’s Innovative Phase I Study: A New Frontier in Cancer Treatment