FDA News and Regulatory Updates

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 disease, 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.

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.

The approval is based on phase 3 trials showing durable IGF-1 control, symptom relief, and a favorable safety profile among adults with acromegaly.

The study found that although PREVENT-generated risk estimates were more consistent in a broad population, PCE estimates were more accurate in those taking statins.

FDA grants Fast Track designation to etalanetug, a promising tau-targeting antibody for Alzheimer disease that could expand treatment options for the neurodegenerative disease.

Seniors remain protected along with any adult or child with underlying risk factors for severe disease, but the healthy US population is left with a choice, so far.

FDA approves guselkumab as the first fully subcutaneous IL-23 inhibitor for ulcerative colitis, showing significant clinical benefits in trials.

Incyte announced the agency's decision, which was based on findings of significant reduction in atopic dermatitis signs and symptoms during the TRuE-AD3 clinical trial.

The updated prescribing information includes phase 3b BATURA trial results showing a 46% reduction in severe exacerbations in mild asthma vs albuterol.

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

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

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

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

FDA clears MiniMed 780G for integration with Abbott’s Instinct sensor and approves its use in insulin-requiring T2D, expanding automated insulin delivery options.

The FDA has accepted a New Drug Application for ensitrelvir, with a PDUFA action date set for June 16, 2026.