FDA News

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.

Review FDA-approved drugs that may soon find a place in your prescribing routine, including new treatments for UTIs, acute pain, migraine, diabetes, and more.

Novo Nordisk aims to revolutionize diabetes care with its resubmission for insulin icodec, a potential first once-weekly basal insulin for type 2 diabetes therapy in adults.