The FDA has approved a 0.25% ophthalmic solution of the ectoparasiticide lotilaner (Xdemvy – Tarsus) for treatment of Demodex blepharitis. Lotilaner is the first drug to be approved in the US for this indication.

The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Taletrectinib (Ibtrozi – Nuvation Bio), an oral kinase inhibitor, has been approved by the FDA for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. It is the fourth oral kinase inhibitor to be approved in the US for this indication; crizotinib (Xalkori), entrectinib (Rozlytrek), and repotrectinib (Augtyro) were approved earlier.

The FDA has approved acoltremon 0.003% ophthalmic solution (Tryptyr – Alcon) for treatment of dry eye disease. Acoltremon is the first transient receptor potential melastatin 8 (TRPM8) thermoreceptor agonist to be approved in the US for this indication.

Sunvozertinib (Zegfrovy – Dizal), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations who had disease progression on or after platinum-based chemotherapy.

Zongertinib (Hernexeos – Boehringer Ingelheim), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of adults with unresectable or metastatic nonsquamous non-small cell lung cancer (NSCLC) with human epidermal growth factor 2 (HER2) tyrosine kinase domain activating mutations who had received prior systemic therapy. It is the first oral targeted therapy to be approved in the US for this indication. The intravenous HER2-directed antibody and topoisomerase inhibitor conjugate famtrastuzumab deruxtecan (Enhertu) was approved for the same indication...

The oral nonergot dopamine agonist pramipexole (Mirapex ER, and generics), which is FDA-approved for treatment of Parkinson's disease and restless legs syndrome, has been used off-label in patients with treatment-resistant depression (TRD). A double-blind, placebo-controlled trial of pramipexole augmentation in patients with unipolar TRD was recently published.

Sevabertinib (Hyrnuo – Bayer), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of adults with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with human epidermal growth factor 2 (HER2) tyrosine kinase domain activating mutations who had received prior systemic therapy. It is the second oral targeted therapy to be approved in the US for this indication; the oral kinase inhibitor zongertinib (Hernexeos) was approved in August 2025.

View the Comparison Table: Some Nonopioid Analgesics for Pain

The FDA has approved nirsevimab-alip (Beyfortus – AstraZeneca/Sanofi), a long-acting monoclonal antibody, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children ≤24 months old who are at increased risk for severe RSV disease through their second RSV season. Nirsevimab is the first drug to be approved for protection of all infants during their first RSV season.