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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Use Authorization allowing administration of the Pfizer vaccine to children 6 months through 4 years old has been withdrawn.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 has approved Lasix ONYU (SQ Innovation), a subcutaneous formulation of the loop diuretic furosemide administered via a wearable pump (onbody infusor), for treatment of edema in adults with chronic heart failure (HF). A similar product, Furoscix, is approved for treatment of edema in chronic HF or chronic kidney disease. Furosemide has been available for years in oral and IV formulations for such use.

In our article titled A Renal Indication for Semaglutide (Ozempic) (Med Lett Drugs Ther 2025; 67:38), the MACE endpoint defined in Table 2, footnote 3 was incorrectly stated as a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or all-cause mortality. All-cause mortality should not have been included in the composite endpoint.

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.

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).

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

Obinutuzumab (Gazyva – Genentech), a CD20-directed monoclonal antibody, has been approved by the FDA for treatment of adults with active lupus nephritis who are receiving standard treatment. It was previously approved for treatment of chronic lymphocytic leukemia and follicular lymphoma. Obinutuzumab is the third drug to be approved in the US for treatment of lupus nephritis; the oral calcineurin inhibitor voclosporin (Lupkynis) and the parenteral B-lymphocyte stimulator (BlyS)-specific inhibitor belimumab (Benlysta) were approved earlier.

The FDA has approved depemokimab (Exdensur – GSK), a long-acting interleukin-5 (IL-5) antagonist, for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in patients ≥12 years old. Depemokimab is the fourth IL-5-directed treatment to be approved in the US for this indication; the IL-5 antagonists mepolizumab (Nucala) and reslizumab (Cinqair) and the IL-5 receptor alpha antagonist benralizumab (Fasenra) were approved earlier.

Ziftomenib (Komzifti – Kura), an oral menin inhibitor, has been approved by the FDA for treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. It is the second oral menin inhibitor to be approved in the US for this indication; revumenib (Revuforj) was approved in October 2025 for use in patients ≥1 year old.

Eylea HD (Regeneron), which contains 8 mg of the vascular endothelial growth factor (VEGF) inhibitor aflibercept, has now been approved by the FDA for intravitreal treatment of macular edema following retinal vein occlusion (RVO). A 2-mg dose of aflibercept (Eylea) was approved previously for this indication. Eylea and Eylea HD are also approved for treatment of neovascular (wet) age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.