FDA News

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

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

The FDA requires all manufacturers of opioid pain medications to revise labeling to emphasize and explain risks with long-term use.

Inclisiran can now be used without a background statin, as an adjunct to changes in diet and physical activity for reduction of LDL-C in hypercholesterolemia.

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.