January 2, 2026
Clinical Updates
Accrufer ® (ferric maltol) – Expanded indication
December 22, 2025 - Shield Therapeutics announced the FDA approval of Accrufer (ferric maltol), for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older.
Clinical Updates
Furoscix® (furosemide) – Expanded indication
December 23, 2025 - MannKind announced the FDA approval of Furoscix (furosemide), for the treatment of edema in pediatric patients weighing 43 kg and above and in adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome.
Clinical Updates
Mounjaro® (tirzepatide) – Expanded indication
December 19, 2025 - The FDA approved Eli Lilly’s Mounjaro (tirzepatide), as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
Clinical Updates
Zynyz® (retifanlimab-dlwr) – Accelerated approval converted to traditional approval
December 17, 2025 - The FDA granted traditional (full) approval of Incyte’s Zynyz (retifanlimab-dlwr), for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
Drug Approvals
Aqvesme™ (mitapivat) – New orphan drug approval
December 23, 2025 - Agios Pharmaceuticals announced the FDA approval of Aqvesme (mitapivat), for the treatment of anemia in adults with alpha- or beta-thalassemia.
Drug Approvals
Boncresa® (denosumab-mobz) – New biosimilar approval
December 22, 2025 - Amneal and mAbxience announced the FDA approval of Boncresa (denosumab-mobz), biosimilar and interchangeable to Amgen’s Prolia® (denosumab).
Drug Approvals
Oziltus® (denosumab-mobz) – New biosimilar approval
December 22, 2025 - Amneal and mAbxience announced the FDA approval of Oziltus (denosumab-mobz), biosimilar and interchangeable to Amgen’s Xgeva® (denosumab).
Drug Approvals
Yartemlea® (narsoplimab-wuug) – New orphan drug approval
December 24, 2025 - Omeros announced the FDA approval of Yartemlea (narsoplimab-wuug), for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).