FDA News and Regulatory Updates

The first oral penem antibiotic, Orlynvah™, has launched in the US, offering a vital treatment option for women with resistant uncomplicated UTIs.

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.

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.

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.