Glofitamab-gxbm (Columvi – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for IV treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, or large B-cell lymphoma (LBCL) arising from follicular lymphoma after ≥2 lines of systemic therapy. Accelerated approval was based on response rates and durability of response. Glofitamab is the second T-cell-engaging bispecific antibody to be approved in the US for treatment of DLBCL; epcoritamab-bysp (Epkinly), which is given...

Betibeglogene autotemcel (Zynteglo — Bluebird Bio), an autologous lentiviral vector cell-based gene therapy, has been approved by the FDA for one-time treatment of transfusion-dependent beta thalassemia in children and adults. Exagamglogene autotemcel (Casgevy), a cell-based gene therapy that uses CRISPR/Cas9 gene-editing technology, was approved earlier this year for the same indication in patients ≥12 years old.

The FDA has approved imetelstat (Rytelo – Geron), a first-in-class telomerase inhibitor, for treatment of low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with transfusion-dependent anemia requiring 4 or more red blood cell (RBC) units over 8 weeks who have not responded to, are no longer responding to, or are ineligible for erythropoiesis-stimulating agents (ESAs).

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.

Linvoseltamab (Lynozyfic – Regeneron), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has received accelerated approval from the FDA for intravenous treatment of relapsed or refractory multiple myeloma in adults who had received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval was based on the response rate and durability of response. Linvoseltamab is the third bispecific BCMA-directed CD3 T-cell engager to be approved for this indication; teclistamab...

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.

Attention-deficit/hyperactivity disorder (ADHD) is a common chronic neurodevelopmental disorder often diagnosed in school-age children that frequently persists into adulthood.Pharmacologic treatment of ADHD has been associated with reduced risks of substance abuse, criminal behavior, unintentional injuries, serious traffic accidents, and all-cause mortality. Drugs approved by the FDA for treatment of ADHD are listed in Table 1.

The FDA has approved Vuity (Abbvie), a 1.25% ophthalmic solution of the muscarinic receptor agonist pilocarpine hydrochloride, for treatment of presbyopia in adults. Pilocarpine 1%, 2%, and 4% ophthalmic solutions (Isopto Carpine, and others) have been available for years for treatment of glaucoma, but local and systemic adverse effects have limited their use.

Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, has been approved by the FDA for add-on maintenance treatment of severe asthma in patients ≥12 years old. It is the first TSLP blocker to become available in the US and the first biologic drug to be approved for treatment of severe asthma without phenotypic or biomarker limitations.

Epsolay (Galderma), a 5% benzoyl peroxide cream, has been approved by the FDA for treatment of inflammatory lesions of rosacea in adults. It is the first product containing benzoyl peroxide to be approved in the US for treatment of rosacea. Benzoyl peroxide formulations approved for acne have been used off-label to treat rosacea for years, but itching and burning have limited their use.