Celltrion announced on October 17, 2025, that the U.S. FDA has approved label expansions for YUFLYMA® (adalimumab-aaty) and its unbranded counterpart, extending treatment to adolescent hidradenitis suppurativa (HS) in patients aged 12 and older and pediatric uveitis (UV) in children aged 2 and older. Previously approved for adult HS and UV, these new indications mark a significant advancement in managing chronic immune-mediated diseases in younger populations.
On October 24, 2025, the U.S. Food and Drug Administration (FDA) approved Lynkuet™ (elinzanetant), developed by Bayer, as the first dual neurokinin (NK) targeted therapy—a combined NK1 and NK3 receptor antagonist—for the treatment of moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, due to menopause. This non-hormonal, once-daily oral therapy addresses a major unmet need in menopausal care, where VMS affect daily functioning, sleep, and quality of life and are a primary reason women seek medical intervention.
On October 23, 2025, the U.S. Food and Drug Administration (FDA) expanded the label for Novo Nordisk’s oral semaglutide (Rybelsus®) to include reduction of major adverse cardiovascular events (MACE)—cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke—in adults with type 2 diabetes mellitus (T2D) and either established cardiovascular disease or high cardiovascular risk, irrespective of prior CV event history. This approval establishes oral semaglutide as the first oral GLP-1 receptor agonist with a cardiovascular indication for both primary and secondary prevention.
On October 20, 2025, the U.S. Food and Drug Administration (FDA) granted approval to Roche’s Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis (LN), a severe complication of systemic lupus erythematosus (SLE) that affects the kidneys. Lupus nephritis is characterized by inflammation that can lead to kidney damage, impaired function, and, in severe cases, kidney failure.
Teva Pharmaceuticals and Medincell announced on October 10, 2025, the U.S. FDA’s approval of an expanded indication for UZEDY® (risperidone) extended-release injectable suspension, now authorized for subcutaneous use as monotherapy or adjunctive therapy to lithium or valproate for maintenance treatment of bipolar I disorder (BD-I) in adults. This marks UZEDY’s second major indication following its 2023 approval for schizophrenia treatment in adults, where it is administered every one or two months.
On October 8, 2025, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Libtayo (cemiplimab-rwlc), a PD-1 inhibitor, as the first and only immunotherapy for adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence following surgery and radiation. This approval, evaluated under Priority Review, is grounded in data from the pivotal Phase 3 C-POST trial, published in the New England Journal of Medicine and presented at ASCO 2025.
