The FDA has approved vutrisiran (Amvuttra – Alnylam), a subcutaneously injected small interfering RNA (siRNA), to reduce cardiovascular hospitalizations, urgent heart failure visits, and cardiovascular death in adults with wild-type or variant transthyretin amyloid cardiomyopathy (ATTR-CM). Vutrisiran is the first siRNA to be approved in the US for this indication; it was approved earlier for treatment of polyneuropathy associated with hereditary transthyretin-mediated amyloidosis.

The FDA has approved imlunestrant (Inluriyo – Lilly), an oral estrogen receptor antagonist, for treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer in adults who had disease progression following at least one prior line of endocrine therapy. Imlunestrant is the second oral selective estrogen receptor degrader (SERD) to be approved in the US for treatment of breast cancer; elacestrant (Orserdu) was approved in 2023.

Obinutuzumab (Gazyva – Genentech), a CD20-directed monoclonal antibody, has been approved by the FDA for treatment of adults with active lupus nephritis who are receiving standard treatment. It was previously approved for treatment of chronic lymphocytic leukemia and follicular lymphoma. Obinutuzumab is the third drug to be approved in the US for treatment of lupus nephritis; the oral calcineurin inhibitor voclosporin (Lupkynis) and the parenteral B-lymphocyte stimulator (BlyS)-specific inhibitor belimumab (Benlysta) were approved earlier.

Ziftomenib (Komzifti – Kura), an oral menin inhibitor, has been approved by the FDA for treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. It is the second oral menin inhibitor to be approved in the US for this indication; revumenib (Revuforj) was approved in October 2025 for use in patients ≥1 year old.

The FDA has approved two new ophthalmic drugs for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension: latanoprostene bunod (Vyzulta – Bausch and Lomb), a modified prostaglandin analog, and netarsudil (VRhopressa – Aerie), the first Rho kinase inhibitor to be approved in the US.

The FDA has approved baloxavir marboxil (Xofluza – Shionogi/Genentech), the first polymerase acidic (PA) endonuclease inhibitor, for single-dose, oral treatment of acute uncomplicated influenza in patients ≥12 years old. Baloxavir is the first drug with a new mechanism of action to be approved for treatment of influenza in almost 20 years.

The FDA has approved daridorexant (Quviviq – Idorsia), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. Daridorexant is the third orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) and lemborexant (Dayvigo) were approved earlier.

Consumption of alcohol has increased during the COVID-19 pandemic. The Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) defines alcohol use disorder (AUD; previously called alcohol dependence) as meeting ≥2 of the 11 criteria listed in Table 1 in the past year. The lifetime prevalence of AUD in the US population has been estimated to be about 30%. Despite this high prevalence and the associated morbidity, mortality, and costs, only 3 drugs are FDA-approved for treatment of the disorder.

Etodolac (Lodine - Wyeth-Ayerst), a nonsteroidal anti-inflammatory drug (NSAID) available in Europe for several years, was recently approved by the U.S. Food and Drug Administration for use in osteoarthritis and as a general-purpose analgesic. It has not been approved for treatment of rheumatoid arthritis.

Disodium pamidronate (Aredia - Ciba-Geigy), an aminohydroxypropilidene bisphosphonate, has been approved by the US Food and Drug Administration for intravenous (IV) treatment of hypercalcemia associated with malignancy, with or without bone metastases. The drug is also being investigated for use in Paget's disease of bone, hyperparathyroidism, and postmenopausal osteoporosis. An oral formulation of pamidronate has been used in Europe, but is not available in the USA.