Ascelia Pharma to Meet With US FDA on Orviglance Drug Application

MT Newswires · 2d ago
06:58 AM EDT, 08/17/2026 (MT Newswires) -- Ascelia Pharma (ACE.ST) said the US Food and Drug Administration scheduled a meeting to discuss the complete response letter issued on its drug application for magnetic resonance imaging contrast agent Orviglance. The Type A meeting is set on Sept. 9, allowing the Swedish biotechnology company to discuss the FDA's concerns outlined in the drug regulator's letter issued on July 2. Ascelia Pharma said it reviewed the agency's comments and implemented the requested actions regarding product quality. The FDA previously said it was unable to approve the Orviglance application in its present form and requested additional clinical data and product documentation.