FDA News

The FDA approved once-daily oral semaglutide 25 mg for chronic weight management and long-term weight maintenance in adults with obesity or overweight, based on data from the OASIS clinical trial program.

Abbott's Volt PFA System gains FDA approval, offering a new minimally invasive treatment for atrial fibrillation, enhancing patient care options.

Phase 3 LIBerate data showed sustained LDL-C reductions of 60% or more in high-risk patients and 50% or more in HeFH, with once-monthly self-administration.

Approval of the novel long-acting mAb was based on the phase 3 SWIFT-1 and SWIFT-2 trials, which showed steep reductions in annualized asthma exacerbations requiring ED or inpatient care.

The mobile-based program targets cognitive processes underlying attention and is intended for use alongside medication, therapy, or education.

Phase 3 results showed durable conversion benefits with a favorable safety profile, informing real-world management of acute PSVT outside of emergency settings.

Zolifodacin is a single-dose oral treatment option for uncomplicated urogenital gonorrhea and one of the first new classes of drugs for the disease in 20 years.

Flow Therapeutics announced approval of its Flow-100 tDCS therapy for depression, which could expand access to non-pharmacologic care and will be available in the US in H2 2026.

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Insulet enhances the Omnipod® 5 system with new glucose targets and algorithms, improving insulin delivery for diabetes management.