FDA Accepts Ascelia Pharma's Orviglance NDA for Review, Sets PDUFA Date of July 3, 2026
May 21, 2026
The FDA has accepted Ascelia Pharma's NDA for Orviglance, a manganese-based oral MRI contrast agent for liver imaging in patients with severe kidney impairment, and set a PDUFA action date of July 3, 2026.