FDA News

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.

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.