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Medical Devices

Capillary Bio Wearable Infusion Set Cleared

FDA clears a Capillary Biomedical 510(k) for its SteadiSet, a wearable infusion set that delivers insulin from a pump to the body for up to three days...

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Medical Devices

GEs Optison OKd for Pediatric Heart Imaging

FDA approves GE HealthCares ultrasound imaging agent Optison 9 for use in pediatric patients.

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Human Drugs

FDA Pulled Into Drug Pricing Fray

A new Trump administration executive order on drug pricing is moving FDA into pricing aspects to help lower drug costs by offering incentives and leve...

Medical Devices

United Imaging X-ray System Cleared

FDA clears a United Imaging 510(k) for its first interventional X-ray system uAngio Aviva.

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Human Drugs

Oncology Office Launches Project Interface

FDAs Oncology Center of Excellence launches Project Interface, a new initiative aimed at deepening engagement with cancer patients, advocacy groups, a...

Biologics

Chikungunya Vaccine on Pause Due to Safety Concerns

U.S. health officials order a temporary pause on the use of the chikungunya vaccine Ixchiq in individuals aged 60 and older following reports of serio...

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Human Drugs

Beam Gets Regenerative Medicine Status for Gene Therapy

FDA grants Beam Therapeutics a Regenerative Medicine Advanced Therapy designation for BEAM-302, a gene therapy designed to correct a disease-causing m...

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Human Drugs

Thermosome Gets Orphan Status on Sarcoma Drug

FDA grants Thermosome an orphan drug designation for THE001 and its use in treating soft tissue sarcomas.

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Human Drugs

Zepbound Beats Wegovy in Trial: Lilly

Eli Lillys Zepbound (tirzepatide) demonstrates significantly greater weight loss than Novo Nordisks Wegovy (semaglutide) in a head-to-head trial of th...

Biologics

CBER Director Prasad on Striking the Right Data Balance

New CBER director Vinay Prasad defends his past criticisms of vaccines and says he is not anti-vax and promises that the Center will strive to always ...