On October 17, 2025, Amgen and AstraZeneca announced that the FDA has approved an additional indication for TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. TEZSPIRE is the first biologic the FDA has approved for the treatment of CRSwNP that targets thymic stromal lymphopoietin (TSLP). According to Amgen and AstraZeneca, “CRSwNP affects up to approximately 320 million people worldwide and is a complex epithelial-driven inflammatory condition characterized by persistent inflammation and benign polyp growths within the nasal cavity,” and “people living with CRSwNP commonly experience airflow obstruction and symptoms including congestion and an impaired sense of smell.” This is the second FDA approved indication for TEZSPIRE, which was approved by the FDA in December 2021 for the add-on maintenance treatment of severe asthma in adult and pediatric patients aged 12 years and older.
Also on October 17, 2025, Celltrion announced that the FDA approved additional pediatric indications for YUFLYMA (adalimumab-aaty) and its unbranded version. The new indications are for the treatment of hidradenitis suppurativa in patients 12 years and older, and uveitis in pediatric patients aged 2 years and older. Though the treatment of these conditions was previously approved in adults, the approval expands the indication of YUFLYMA (and its unbranded counterpart) to younger patient populations. YUFLYMA was originally approved by the FDA in September 2023.