AMRX Amneal

Amneal gains FDA approval for additional iohexol strengths and presentations

FDA approved iohexol injection 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials plus 300 mg iodine/mL in 50 mL vial. These new presentations complement the previously approved 300 mg iodine/mL in 100 mL vial, expanding Amneal’s portfolio to address the majority of U.S. iohexol demand. The approvals are the first generic versions referencing OMNIPAQUE across the approved presentations.

Zambon/Amneal: CHMP positive opinion for Hopledo (IPX203) in Parkinson’s

CHMP adopted a positive opinion recommending EMA marketing authorization for Hopledo (modified-release levodopa/carbidopa) in adults with Parkinson’s disease and moderate to severe motor fluctuations. The opinion is based on the Phase 3 RISE-PD trial showing increased Good ON time with fewer daily doses versus immediate-release levodopa/carbidopa. If approved by the European Commission, Zambon plans phased European launch starting October 2026.

Amneal Pharmaceuticals, Inc. Class A · FDA licenses Boncresa (denosumab-mobz)

FDA's Purple Book lists BLA 761456 (Boncresa, denosumab-mobz; Amneal Pharmaceuticals LLC, CDER) as licensed on 2025-12-19.