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The FDA has approved ensitrelvir (Xocova – Shionogi), a SARS-CoV-2 main protease inhibitor, for postexposure prophylaxis of COVID-19 in patients ≥12 years old who had contact with an infected individual. Ensitrelvir is the first oral antiviral drug to be approved in the US for this indication. The parenteral monoclonal antibody combinations bamlanivimab and etesevimab and casirivimab and imdevimab (REGEN-COV) are no longer authorized for postexposure prophylaxis of COVID-19 in the US.

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 now requires a warning about a risk of acute kidney injury in the product label for the 60-mg capsules of the pancreatic and gastric lipase inhibitor orlistat, which are available over the counter as Alli for weight loss.1 The label for the 120-mg capsules, which are available by prescription as Xenical, already includes a warning about a risk of oxalate nephrolithiasis and oxalate nephropathy (orlistat increases oxalate absorption).

Initial treatment of allergic rhinitis (AR) depends on the severity of symptoms and whether they are intermittent or persistent (see Table 1).

Most respiratory tract infections are caused by viruses. Bacterial respiratory tract infections are usually treated empirically with antibiotic therapy that targets the most probable causative pathogens. Recommended antibiotic regimens for outpatient treatment of some common respiratory tract infections are listed in Table 1 for adults and Table 2 for children.

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 children 6 months through 4 years old has been withdrawn.

Adults with persistent fasting triglyceride levels ≥150 mg/dL are considered to have hypertriglyceridemia; when levels are ≥500 mg/dL, it is considered severe. Hypertriglyceridemia is associated with an increased risk of atherosclerotic cardiovascular disease (ASCVD); severe hypertriglyceridemia increases the risk of acute pancreatitis.

Influenza is generally a self-limited illness, but complications including pneumonia, respiratory failure, and death can occur, especially in persons at increased risk (see Table 1).

The FDA has approved Omlonti (Ocuvex), a 0.002% ophthalmic solution of the prostaglandin EP₂ receptor agonist omidenepag isopropyl, for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Omidenepag is the first selective prostaglandin EP₂ receptor agonist to be approved in the US. It has been available in Japan since 2018.

The FDA has granted accelerated approval to the B-cell lymphoma 2 (BCL-2) inhibitor sonrotoclax (Beqalzi – BeOne Medicines) for treatment of relapsed or refractory mantle cell lymphoma (MCL) in adults who received ≥2 prior lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor (e.g., pirtobrutinib [Jaypirca]), acalabrutinib [Calquence], or zanubrutinib [Brukinsa]). Sonrotoclax is the first BCL-2 inhibitor to be approved in the US for this indication. The BCL-2 inhibitor venetoclax (Venclexta) has been used off label for third-line treatment of MCL.