Most Read Articles

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 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Use Authorization allowing administration of the Pfizer vaccine to children 6 months through 4 years old has been withdrawn.

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).

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.

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

Bemotrizinol (bis-ethylhexyloxyphenol methoxyphenol triazine), a broad-spectrum, organic ultraviolet (UV) filter that has been available in Europe since 2000, is the first new active ingredient with broad availability to be added to the FDA's OTC sunscreen monograph in more than 25 years, and the first organic UV filter to be generally recognized as safe and effective (GRASE). Data with other organic UV filters are insufficient for a GRASE designation.

The FDA has approved the oral interleukin (IL)-23 receptor antagonist icotrokinra (Icotyde – Janssen) for treatment of moderate to severe plaque psoriasis in patients ≥12 years old who are candidates for systemic treatment or phototherapy. Icotrokinra is the first oral targeted interleukin blocker to become available in the US.

View the Comparison Chart: Some Vaccines for Adults

Sibeprenlimab (Voyxact – Otsuka), a subcutaneously injected cytokine A proliferation-inducing ligand (APRIL) blocker, has been granted accelerated approval by the FDA to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk for disease progression. Sibeprenlimab is the first APRIL blocker to be approved in the US. Atacicept (Trutakna), a B-lymphocyte stimulator and APRIL blocker, was recently granted accelerated FDA approval for the same indication; it will be reviewed in a future issue.