Bayer Reports the US FDA’s NDA Acceptance of Gadoquatrane for Contrast-Enhanced MRI

Shots:The US FDA has accepted NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. neonates; MAA was submitted to MHLW & EMA with further filings planned in other regionsNDA was supported by the QUANTI clinical program, which incl.…

ByRidhi RastogiAugust 27, 2025

NEWS

Bayer Reports the US FDA’s NDA Submission of Gadoquatrane for Contrast-Enhanced MRI

Shots:The US FDA has received NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. term neonates; MAA was submitted to MHLW with further filings planned in coming mos.NDA was supported by the QUANTI clinical program, which incl. 2…

ByRidhi RastogiJune 18, 2025

NEWS

Bayer Presents P-III (QUANTI CNS) Trial Data of Gadoquatrane at European Congress of Radiology 2025

Shots:The P-III (QUANTI CNS) trial assessed GBCA gadoquatrane (0.04mmol Gd/kg) vs macrocyclic GBCAs (0.1mmol Gd/kg) in adults (n=305) with confirmed or suspected CNS pathologies undergoing contrast-enhanced MRI Study showed non-inferiority (1EP) & superiority across all visualization criteria (contrast enhancement, delineation, & morphology), plus higher sensitivity & specificity (2EP) for lesion detection & exclusion…

ByRidhi RastogiFebruary 27, 2025

NEWS

Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRI

Shots:The P-III (QUANTI; N=808) trials of gadoquatrane (0.04mmol Gd/kg body wt.) comprised of QUANTI CNS for CNS disorders like brain tumors, brain metastasis & multiple sclerosis; QUANTI OBR for other body regions like head & neck, thorax, abdomen & pelvis as well as QUANTI Pediatric study for children (birth to 18yrs.) Study assessed…

ByRidhi RastogiJanuary 13, 2025

Bayer Reports the US FDA’s NDA Acceptance of Gadoquatrane for Contrast-Enhanced MRI

Bayer Reports the US FDA’s NDA Submission of Gadoquatrane for Contrast-Enhanced MRI

Bayer Presents P-III (QUANTI CNS) Trial Data of Gadoquatrane at European Congress of Radiology 2025

Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRI

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