The FDA has approved tebentafusp-tebn (Kimmtrak – Immunocore), a first-in-class bispecific gp100 peptide-HLA-directed CD3 T-cell engager, for treatment of HLA-A*02:01-positive unresectable or metastatic uveal melanoma in adults.

Elecsys Phospho-Tau (181P) Plasma (Roche), a blood-based diagnostic test, has been cleared by the FDA to aid in the initial assessment of amyloid plaque pathology associated with Alzheimer's disease (AD) in patients ≥55 years old with signs of cognitive decline. It is the second blood test for AD biomarkers to be cleared by the FDA; the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test was cleared in 2025 (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.

Proton pump inhibitors (PPIs), which are used for treatment of gastroesophageal reflux disease (GERD) and for prevention of upper gastrointestinal adverse effects caused by NSAIDs and aspirin, are one of the most commonly prescribed classes of drugs in the US. All PPIs are similarly effective and generally well tolerated, but their long-term use has been associated with a number of safety concerns. Recommendations addressing these concerns have recently been published.

Recently published results of a large, carefully conducted retrospective study indicated that use of the antibiotic azithromycin (Zithromax, and others) may increase the risk of cardiovascular death, especially in patients with a high baseline risk of cardiovascular disease.1 One possible mechanism is prolongation of the QT interval, which is known to occur rarely with azithromycin and more frequently with the other macrolide antibiotics erythromycin (Erythrocin, and others) and clarithromycin (Biaxin, and others).Among the patients who received 347,795 prescriptions for azithromycin, there...

The FDA has approved the marketing of another extended-release brand-name formulation of the serotonin and norepinephrine reuptake inhibitor (SNRI) desvenlafaxine (Khedezla – Par/Osmotica) for treatment of depression. It is the third extended-release formulation of desvenlafaxine to become available in the US. Khedezla was approved using a 505(b)(2) application, a new drug application (NDA) that relies upon the FDA's findings of safety and/or effectiveness for a previously approved drug.Khedezla does not appear to offer any advantage over the other extended-release formulations of...

Lisdexamfetamine dimesylate (Vyvanse), a prodrug of dextroamphetamine previously approved for treatment of attention-deficit/hyperactivity disorder, has now been approved for treatment of moderate-to-severe binge eating disorder (recurrent episodes of compulsive overeating without purging) in adults.FDA approval of lisdexamfetamine for this indication was based on two unpublished, 12-week trials, summarized in the package insert, that randomized patients with moderate-to-severe binge eating disorder to lisdexamfetamine 30 mg/day, which was titrated to 50 mg or, if needed, 70 mg, or to placebo....

IV antiviral drug remdesivir (Veklury) has now been FDA-approved for treatment of COVID-19 in patients ≥28 days old who weigh ≥3 kg and are either hospitalized or at high risk for progression to severe disease. Remdesivir was already FDA-approved for these indications in patients ≥12 years old who weigh ≥40 kg; it was available under an Emergency Use Authorization (EUA) for younger or lighter patients. Remdesivir is the first drug to be FDA-approved for treatment of COVID-19 in children <12 years old.

Gamma hydroxy butyrate (GHB) sold in health food stores has recently caused outbreaks of gastrointestinal illness, central-nervous-system (CNS) depression, and seizures.

The FDA has approved the marketing of RotaShield, a live oral vaccine for prevention of infantile rotavirus infection. Rotaviruses are segmented double-stranded RNA viruses that are the most common cause of severe diarrhea and dehydration in infants and young children.