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Medical Devices

InspireMD PMA Approved for Carotid Stent

FDA approves an InspireMD PMA for its CGuard Prime Carotid Stent System for treating carotid artery stenosis.

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Medical Devices

Cook Medical Recalls Beacon Angiographic Catheter

Cook Medical recalls its Beacon Tip 5.0 Fr Angiographic Catheter because it may experience tip separation.

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Human Drugs

Sterling Drug Supply Chain Violations

FDA warns Sterling Distributors about its multiple violations of the Drug Supply Chain Security Act.

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Human Drugs

Guide on Developing Drugs for Lyme Disease

FDA posts a final guidance entitled Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment.

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Human Drugs

Lillys Amyvid Gets Updated Label

FDA approves an updated label for Eli Lillys Amyvid (florbetapir F 18 injection) for brain imaging to estimate amyloid plaque density in patients bein...

Biologics

FDA Approves New Warnings on Covid mRNA Vaccines

FDA requires and approves updates to the prescribing information for Pfizers Comirnaty Covid-19 mRNA vaccine and Modernas Spikevax Covid-19 mRNA vacci...

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Human Drugs

Stop FDAs Sudden Biosecurity Overreach: Newsletter

A Global Biodefense online post says FDAs sudden decision to halt clinical trials that send samples overseas for processing can hurt the nations biote...

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Human Drugs

Makarys FDA Voucher Program Questioned

UPenn medical school professor Holly Lynch says there are many questions about the new FDA Commissioners National Priority Voucher program, including ...

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Human Drugs

House Committee Advances FDA Budget Bill

The U.S. House Appropriations Committee advances in a 35 to 27 vote FDAs fiscal year 2026 spending bill.

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Medical Devices

Safety Alert on Medtronic Esophagus pH Monitor

FDA posts a safety alert on Medtronic subsidiary Given Imaging and certain Bravo CF Capsule delivery devices, which are designed to monitor pH in a pa...