The FDA has approved inclisiran (Leqvio – Novartis), a small interfering RNA (siRNA) directed to proprotein convertase subtilisin/kexin type 9 (PCSK9) mRNA, as an adjunct to diet and maximally tolerated statin therapy for subcutaneous (SC) treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Inclisiran is the first FDA-approved PCSK9-directed siRNA therapeutic agent.

Faricimab-svoa (Vabysmo – Genentech), an inhibitor of both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), has been approved by the FDA for intravitreal treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). It is the first drug to become available in the US that targets two pathways involved in maintaining vascular homeostasis. Several VEGF inhibitors are available for treatment of nAMD and DME (see Table 2).

The FDA has approved the recombinant chimeric anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Two other anti-CD20 antibodies, IV ocrelizumab (Ocrevus) and SC ofatumumab (Kesimpta), are also FDA-approved for these indications.

The FDA has approved a subcutaneously injected, extended-release formulation of the mu-opioid receptor partial agonist and kappa-opioid receptor antagonist buprenorphine (Brixadi – Braeburn) for once-weekly or once-monthly treatment of moderate to severe opioid use disorder. Brixadi is the second subcutaneously injected buprenorphine formulation to be approved in the US; Sublocade, which is administered once monthly, was the first. Buprenorphine is also available for treatment of opioid use disorder in sublingual formulations with and without the opioid antagonist...

Attention-deficit/hyperactivity disorder (ADHD) is a common chronic neurodevelopmental disorder often diagnosed in school-age children that frequently persists into adulthood.Pharmacologic treatment of ADHD has been associated with reduced risks of substance abuse, criminal behavior, unintentional injuries, serious traffic accidents, and all-cause mortality. Drugs approved by the FDA for treatment of ADHD are listed in Table 1.

The primary symptoms of menopause are genitourinary and vasomotor. The genitourinary syndrome of menopause (GSM) includes symptoms such as burning, irritation, dryness, dyspareunia, dysuria, and recurrent urinary tract infection. Vasomotor symptoms (VMS; hot flashes, night sweats) often disrupt sleep.

The FDA has approved two new drugs for treatment of previously-treated unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer: fam-trastuzumab deruxtecannxki (Enhertu – Daiichi-Sankyo/AstraZeneca), an IV HER2-directed monoclonal antibody linked to the topoisomerase I inhibitor DXd, and tucatinib (Tukysa – Seagen), an oral tyrosine kinase inhibitor.

The FDA has approved mavacamten (Camzyos – MyoKardia/BMS), a modulator of cardiac myosin, to improve functional capacity and symptoms in adults with New York Heart Association (NYHA) class II or III obstructive hypertrophic cardiomyopathy (HCM) who have a baseline left ventricular ejection fraction (LVEF) ≥55%. Mavacamten is the first drug in its class to become available in the US.

The FDA has approved tirzepatide (Mounjaro – Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve glycemic control in adults with type 2 diabetes. Tirzepatide, which is injected subcutaneously once weekly, is the first dual GIP/GLP-1 receptor agonist to become available in the US. Selective GIP receptor agonists are not available in the US; GLP-1 receptor agonists have been available for years.

The FDA has licensed new 2025-2026 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax, mNEXSPIKE) and the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax (Nuvaxovid). The new formulations are indicated for use in all adults ≥65 years old and in persons 6 months (Spikevax), 5 years (Comirnaty), or 12 years (mNEXSPIKE, Nuvaxovid) through 64 years old who are at high risk for severe COVID-19 because of an underlying condition. An Emergency Use Authorization allowing administration of the Pfizer vaccine to...