FDA News

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

FDA grants Fast Track designation to rezpegaldesleukin for severe alopecia areata, highlighting its potential to meet critical treatment needs.

FDA approval based on FINEARTS-HF trial showing 16% risk reduction in CV death and HF events.

Moderna’s Spikevax receives full FDA approval for use in children at increased risk for COVID-19, expanding protection ahead of the 2025–2026 virus season.

The adjusted dosing for donanemab in early AD reduced ARIA-E risk by 41% compared to the original dosing, without compromising efficacy.

Dupilumab is the first targeted treatment for BP 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.