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FDA Wants Public Deregulation Input

FDA and HHS ask public stakeholders for their ideas on regulations that should be eliminated.

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Human Drugs

CGMP Violations at Excelvision Fareva

FDA warns Frances Excelvision Fareva about CGMP violations in its production of finished drugs.

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Human Drugs

FDA Moves to Ban Pediatric Ingestible Fluoride Drugs

FDA plans to remove from the market concentrated ingestible fluoride prescription drug products for children, citing safety concerns and a lack of for...

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Human Drugs

Assertio Pays $3.6 Million Over Improper Marketing

Assertio Therapeutics agrees to pay $3.6 million to resolve claims that it violated the False Claims Act by causing the submission of false claims abo...

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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...

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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...