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.

The FDA has approved two antibiotics, gepotidacin (Blujepa — GSK) and zoliflodacin (Nuzolvence — Entasis), for oral treatment of uncomplicated urogenital gonorrhea in patients ≥12 years old. Gepotidacin is approved for use in persons weighing ≥45 kg who have limited or no alternative treatment options; it was approved in 2025 for treatment of uncomplicated urinary tract infection in females. Zoliflodacin is approved for use in persons weighing ≥35 kg. Neither drug is indicated for treatment of rectal or pharyngeal gonorrhea.

The FDA has approved oteseconazole (Vivjoa – Mycovia), a new oral azole antifungal, to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC. Oteseconazole is the first drug to be approved in the US specifically for treatment of RVVC.

Fam-trastuzumab deruxtecan (Enhertu – Daiichi Sankyo/AstraZeneca) has now been approved by the FDA for use in combination with pertuzumab (Perjeta) for first-line treatment of HER2-positive unresectable or metastatic breast cancer. The drug was approved earlier for use as monotherapy in adults with previously treated HER2-positive unresectable or metastatic breast cancer.

The FDA has approved a 12.5-mg tablet formulation of the thiazide-like diuretic chlorthalidone (HemiClor – Ingenus) for treatment of hypertension. Chlorthalidone has been available for years in 15-, 25-, and 50-mg tablets (Thalitone, and generics) and in fixed-dose combinations with azilsartan medoxomil (Edarbyclor) and atenolol (Tenoretic, and generics).

Fam-trastuzumab deruxtecan-nxki (Enhertu – Daiichi Sankyo/AstraZeneca), which received accelerated approval by the FDA in 2019 for treatment of HER2-positive breast cancer based on its rate and duration of response,1 has been granted regular approval for treatment of adults with unresectable or metastatic HER2-positive breast cancer who received a prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and developed recurrence during or within 6 months of completing treatment.

The tissue plasminogen activator (tPA) tenecteplase (TNKase – Genentech) has been approved by the FDA for treatment of acute ischemic stroke in adults. It is the second tPA to be approved in the US for this indication; alteplase (Activase) was approved in 1996. Tenecteplase was approved in 2000 to reduce the risk of death associated with acute ST-elevation myocardial infarction (STEMI).

The FDA has approved Rebyota (Ferring), a rectally-administered, live fecal microbiota suspension, for prevention of additional recurrences of Clostridioides difficile infection (CDI) following antibiotic treatment for a recurrent episode of CDI in adults. Rebyota is the first microbiome-based treatment to be approved for this indication. It is not approved for initial treatment of CDI. Fecal microbiota transplantation (FMT) has been used in patients with multiple CDI recurrences.

The direct oral anticoagulants (DOACs) apixaban (Eliquis) and rivaroxaban (Xarelto, and generics) are frequently used for treatment of acute venous thromboembolism (VTE) and are usually continued for at least 3 months. The other DOACs (edoxaban [Savaysa] and dabigatran [Pradaxa, and generics]) are alternatives for long-term treatment, but they require prior treatment with low-molecular-weight heparin for ≥5 days. Until recently, no large randomized trial directly comparing the safety of apixaban and rivaroxaban for treatment of VTE was available.

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy), which was approved by the FDA in 2021 for chronic weight management in adults, has now been approved for chronic weight management in children ≥12 years old with an initial BMI in the ≥95th percentile for age and sex.Semaglutide is also available as Ozempic and Rybelsus for treatment of type 2 diabetes in adults.