FDA News

AstraZeneca launches FluMist Home, the first FDA-approved at-home flu vaccine service, allowing self- or caregiver administration of the intranasal influenza vaccine for the 2025–26 season.

The accelerated approval for semaglutide 2.4 mg for the treatment of noncirrhotic MASH was based on part 1 of the phase 3 ESSENCE trial, which met its primary endpoints.

The US FDA approved Tonmya, a groundbreaking treatment for fibromyalgia, offering hope to millions experiencing chronic pain and sleep issues.

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

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

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

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.