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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...

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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...

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 ...

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Human Drugs

Parkinsons Therapy Gets Regenerative Medicine Status

FDA grants MeiraGTx Holdings a regenerative medicine advanced therapy designation for gene therapy AAV-GAD and its use for treating Parkinsons disease...

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FDA General

FDA Preparing for Drug User Fee Negotiations

FDA prepares to begin negotiation sessions in September to reauthorize the Prescription Drug User Fee Act, which expires 9/2027.

Biologics

Makary Says Novavax BLA Decision is Forthcoming

FDA commissioner Marty Makary says discussions are continuing with Novavax on its BLA to convert a 2022 emergency use authorization to a full approval...