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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 ...

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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...