FDA News

COVID-19 Infection Raises Risk of Asthma and Other Respiratory Type-2 Inflammatory Diseases
August 15, 2025

Large US cohort study finds COVID-19 infection increases short-term risk of asthma, allergic rhinitis, and chronic rhinosinusitis, while vaccination lowers these risks.

FDA Approves Brensocatib for Non–Cystic Fibrosis Bronchiectasis
August 14, 2025

The US FDA approved brensocatib as the first treatment for non–cystic fibrosis bronchiectasis.

FDA Accepts Gepotidacin for Priority Review for the Treatment of Uncomplicated Urogenital Gonorrhea
August 11, 2025

FDA accepts priority review of gepotidacin for uncomplicated urogenital gonorrhea, with phase 3 data showing non-inferiority to standard injectable therapy.

FDA Approves Finerenone for Treatment of Heart Failure With LVEF ≥40%: Daily Dose
August 08, 2025

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

FDA OKs Shingrix Prefilled Syringe: Daily Dose
August 05, 2025

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

FDA Mandates Major Changes to Opioid Labeling
August 04, 2025

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

FDA Label Update Positions Inclisiran as First-Line Monotherapy for Hypercholesterolemia
August 01, 2025

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.

New Option for Chronic Hand Eczema Gets FDA Green Light: Daily Dose
August 01, 2025

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

FDA Grants Fast Track Designation to Rezpegaldesleukin for Alopecia Areata
July 31, 2025

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

FDA Approves Finerenone for Heart Failure With LVEF ≥40% Following Positive Phase 3 Data
July 14, 2025

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