August 29, 2025
Clinical Updates
Repatha® (evolocumab) – Expanded/updated indications
August 25, 2025 - Amgen announced the FDA approval of Repatha (evolocumab), to reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events.
Clinical Updates
Thrombate III® (antithrombin III [human]) – Expanded indication
August 21, 2025 - The FDA approved Grifols Therapeutics’ Thrombate III (antithrombin III [human]), in adult and pediatric patients with hereditary antithrombin deficiency for treatment and prevention of thromboembolism and prevention of peri-operative and peri-partum thromboembolism.
Drug Approvals
Cyklx™ (articaine) – New drug approval
August 15, 2025 - The FDA approved American Genomics’ Cyklx (articaine), for ocular surface anesthesia prior to ocular procedures and/or intraocular injections in adults and pediatric patients.
Drug Approvals
Dawnzera™ (donidalorsen) – New orphan drug approval
August 21, 2025 - Ionis announced the FDA approval of Dawnzera (donidalorsen), for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.
Drug Approvals
Eligard® (leuprolide) – First-time authorized brand alternative
August 4, 2025 - UroNova launched an authorized brand alternative of Tolmar’s Eligard (leuprolide) 22.5 mg and 45 mg injection.
Drug Safety
Ixchiq® (chikungunya vaccine, live) – FDA suspends biologics license
August 22, 2025 - The FDA’s Center for Biologics Evaluation and Research (CBER) announced that they suspended the biologics license for Valneva’s Ixchiq (chikungunya vaccine, live).