FDA News

Dupilumab is the first targeted treatment for B to receive FDA approval, showing improved remission rates, itch reduction, and lower steroid use in pivotal trial.

The FDA cleared Happy Ring, a wearable device for at-home diagnosis of sleep disorders, enhancing access to vital sleep health solutions.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026.

The novel triple fixed-dose combination of telmisartan, amlodipine and indapamide, is the first of its kind approved for initial treatment of hypertension.

The preventive monoclonal antibody is designed to protect infants against RSV infection through 5 months and is administered at the same dose, regardless of weight.

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

FDA panel endorses continued use of monovalent JN.1 strain for COVID-19 vaccines, aligning with global health recommendations amid evolving variants.

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

Mepolizumab, an IL-5 inhibitor targeting Th2 inflammation characterized by elevate serum eosinophil count, fills a treatment gap for ~70% of adults with uncontrolled COPD.

The diagnostic is designed to help clinicians determine the likelihood of cerebral β-amyloid plaque deposition, one of the neuropathologic hallmarks of AD.