The U.S. Food and Drug Administration (FDA) has rejected Ascelia Pharma's application for Orviglance, a new manganese-based oral contrast imaging agent for MRI visualization of liver lesions. The FDA cited inadequate evidence of effectiveness from clinical trials, specifically that only one of three readers showed the superiority of the new imaging method. The agency requested a new controlled study with appropriate reader training to address these concerns. Ascelia Pharma plans to meet with the FDA to discuss the feedback and clarify its position, while emphasizing that it has already implemented a revised image-reading process. Additionally, this rejection was included in the recent FDA transparency initiative, which has faced challenges from industry stakeholders regarding the disclosure of application responses.
Sun, 26 Jul 2026 23:51:53 GMT | Radiology Business