FDA News

Your daily dose of the clinical news you may have missed.

Catch up on the 7 FDA drug approvals from Q3 2025 most relevant to primary care, including new treatments for cardiometabolic, infectious, and inflammatory diseases.

FDA approves updated indication for upadacitinib in ulcerative colitis and Crohn disease treatment, allowing use after one systemic therapy when TNF blockers are clinically inadvisable.

Your daily dose of the clinical news you may have missed.

Roche's Elecsys pTau181 test has a 97.9% negative predictive value to rule out amyloid pathology, which will improve referral decisions and expedite treatment.

The approval of roflumilast 0.05% provides a steroid-free, once-daily treatment option for safe and effective long-term management of pediatric eczema.

FDA did not announce the September 30 approval, which took place despite strong partisan opposition and during an uncompleted review of the drug's safety.

Remibrutinib is the first oral BTK inhibitor for chronic spontaneous urticaria, with a dual mechanism of action that blocks 2 key autoimmune mechanisms.

The FDA has granted fast track designation to BMS-986446, an anti–microtubule binding region tau antibody in phase 2 trials for early Alzheimer disease.

The FDA has approved guselkumab for children aged 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis, making it the first IL-23 inhibitor authorized for pediatric use.