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RxNews®

Valuable and timely information on drug therapy issues impacting today's health care and pharmacy environment.

February 13, 2026

Drug Approvals

Ozempic® (semaglutide) tablets – New formulation approval

February 4, 2026 - Novo Nordisk announced the FDA approval of Ozempic (semaglutide) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) and to reduce the risk of major adverse cardiovascular (CV) events (MACE) (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with T2DM who are at high risk for these events.

Drug Approvals

Quiofic™ (folic acid) – New drug approval

January 26, 2026 - The FDA approved Solubiomix’s Quiofic (folic acid), for the treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients.

Drug Approvals

Vykoura™ (leucovorin) – New drug approval

February 3, 2026 - The FDA approved Avyxa Pharma’s Vykoura (leucovorin) for rescue after high-dose methotrexate therapy in adult and pediatric patients; reducing the toxicity of methotrexate in adult and pediatric patients with impaired methotrexate elimination or folic acid antagonists or dihydrofolate reductase inhibitors following an overdose in adult and pediatric patients; treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible; treatment of patients with metastatic colorectal cancer in combination with fluorouracil.