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Human Drugs

GSK, iTeos Therapeutics Scrap Lung Cancer Candidate

GSK and iTeos Therapeutics decide to stop the development of belrestotug, an anti-TIGIT monoclonal antibody for treating certain non-small cell lung c...

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Human Drugs

FDA Needs GLP-1 Long-Range Plan: Kessler

Former FDA commissioner David Kessler, who is taking one of the new weight loss drugs, calls on FDA to require data to help people come off the drugs ...

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.