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...

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 FDA has recommended additional MRI monitoring during initiation of treatment with the amyloid beta-directed monoclonal antibody lecanemab-irmb (Leqembi) and has approved a new subcutaneously injected formulation of the drug (Leqembi Iqlik) for maintenance treatment of Alzheimer's disease.

Dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously injected interleukin (IL)-4 receptor alpha antagonist that is FDA-approved for several indications, including treatment of chronic rhinosinusitis with nasal polyps, has now been approved for treatment of allergic fungal rhinosinusitis (AFRS) in patients ≥6 years old who previously had sinonasal surgery. It is the first drug to be approved in the US for this indication.

The FDA has granted accelerated approval to the B-cell lymphoma 2 (BCL-2) inhibitor sonrotoclax (Beqalzi – BeOne Medicines) for treatment of relapsed or refractory mantle cell lymphoma (MCL) in adults who received ≥2 prior lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor (e.g., pirtobrutinib [Jaypirca]), acalabrutinib [Calquence], or zanubrutinib [Brukinsa]). Sonrotoclax is the first BCL-2 inhibitor to be approved in the US for this indication. The BCL-2 inhibitor venetoclax (Venclexta) has been used off label for third-line treatment of...

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 Akynzeo (Helsinn/Eisai), an oral fixed-dose combination of the substance P/neurokinin 1 (NK1) receptor antagonist netupitant and the serotonin-3 (5-HT3) receptor antagonist palonosetron, for prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy in adults. Akynzeo is the first product to combine drugs from these two classes. Palonosetron (Aloxi) is also available as a single agent for prevention of chemotherapy-induced and postoperative nausea and vomiting. Netupitant is the second substance P/NK1 receptor antagonist to be...