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Syndax Gets Priority Review for Revuforj sNDA

[ Price : $8.95]

FDA grants Syndax Pharmaceuticals a priority review of its supplemental NDA for Revuforj (revumenib) as a treatment for relapsed o...

Reverse FDA Restructuring: Former GOP Representative

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Former GOP Rep. John Doolittle calls for immediate steps to reverse some of the FDA restructuring that he says will hurt regulated...

InspireMD PMA Approved for Carotid Stent

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

Cook Medical Recalls Beacon Angiographic Catheter

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

Sterling Drug Supply Chain Violations

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

Guide on Developing Drugs for Lyme Disease

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

Lillys Amyvid Gets Updated Label

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

FDA Approves New Warnings on Covid mRNA Vaccines

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

Stop FDAs Sudden Biosecurity Overreach: Newsletter

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

Makarys FDA Voucher Program Questioned

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