Pharmacologic treatment is recommended for postmenopausal women who have bone density T-scores (standard deviations from normal mean values in the spine, femoral neck, total hip, or distal radius) of -2.5 or below, T-scores between -1.0 and -2.5 with a history of fragility (low-trauma) fracture of the hip or spine, or T-scores between -1.0 and -2.5 with a FRAX 10-year probability of ≥3% for hip fracture or ≥20% for major osteoporotic fracture.

This review includes recommendations for the treatment of common sexually transmitted infections (STIs) other than HIV and viral hepatitis in nonpregnant adolescents and adults. Some of the indications and dosages included here have not been approved by the FDA.

The FDA has approved adjunctive treatment with Dartisla ODT (Edenbridge), a new orally disintegrating tablet (ODT) formulation of the anticholinergic drug glycopyrrolate, to reduce symptoms of a peptic ulcer. Glycopyrrolate oral tablets (Robinul, Robinul Forte, and generics) were approved for the same indication in 1961.

The FDA is requiring a boxed warning in the label of denosumab (Prolia – Amgen), a monoclonal antibody that inhibits osteoclasts, about an increased risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD; eGFR <30 mL/min/1.73 m²), particularly those on dialysis. FDA-approved indications for Prolia are listed in Table 1.

The FDA has approved a new titration regimen for donanemab (Kisunla – Lilly), an IV amyloid beta-directed monoclonal antibody indicated for treatment of Alzheimer's disease. The new regimen is intended to reduce the risk of serious amyloid-related imaging abnormalities (ARIA) associated with use of the drug.

The FDA has requested the removal of the suicidal behavior and ideation warning from the labels of the 3 glucagon-like peptide-1 (GLP-1) receptor agonists approved for chronic weight management: liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound). The warning was initially included in the labels of these drugs based on an increased risk of suicidal behavior and ideation observed with older weight loss drugs.

Differin Epiduo gel (Galderma), a fixed-dose combination of the synthetic retinoid adapalene 0.1% and the oxidizing agent benzoyl peroxide 2.5%, is now available over the counter (OTC) for topical treatment of acne in patients ≥12 years old. It will remain available by prescription for use in patients 9-11 years old. A gel containing adapalene 0.3% and benzoyl peroxide 2.5% (Epiduo Forte, and generics) is available by prescription for use in patients ≥12 years old.

The FDA has approved Vowst (Seres Therapeutics/Nestle HealthScience), an oral capsule containing live fecal microbiota spores, for prevention of additional recurrences of Clostridioides difficile infection (CDI) in adults. Vowst is the first orally administered microbiota-based treatment to be approved for this indication. A rectally-administered live fecal microbiota-based suspension (Rebyota) was approved in 2022 for the same indication. Neither product is approved for acute treatment of CDI.

Fezolinetant (Veozah – Astellas), a first-in-class neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the second nonhormonal treatment to be approved in the US for this indication; a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle) was approved in 2013.

The FDA recently expanded the eligibility criteria (see Table 1) for treatment with the surgically implanted hypoglossal nerve stimulation system (Inspire Upper Airway Stimulation – Inspire Medical Systems). The device has been advertised lately on radio and television.