FDA News

FDA Approves Updated Indication Statement for Upadacitinib in Inflammatory Bowel Disease Treatment
October 14, 2025

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.

FDA OKs Subcutaneous Guselkumab Regimen for Ulcerative Colitis: Daily Dose
October 14, 2025

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

FDA Clears First Blood Test to Rule Out Alzheimer-Related Pathology in Primary Care
October 13, 2025

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.

FDA Expands Indication for Roflumilast to Treat Atopic Dermatitis in Children Aged 2 to 5 Years
October 06, 2025

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 Quietly Approves Another Generic Formulation of Abortion Drug Mifepristone
October 03, 2025

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.

Novartis' Oral Targeted BTKi Treatment Approved for Chronic Spontaneous Urticaria in Adults
October 02, 2025

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

FDA Grants Fast Track Designation to Anti-MTBR Tau Antibody BMS-986446 for Alzheimer Disease
October 01, 2025

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.

FDA Approves Guselkumab for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis
September 30, 2025

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.

10 Drugs Approved for Primary Care From the First Half of 2025
September 29, 2025

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 Resubmits Insulin Icodec Injection to FDA for Potential First Once-Weekly Basal Insulin Therapy for T2D
September 29, 2025

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.