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Lillys Amyvid Gets Updated Label

[ Price : $8.95]

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...

Syndax Gets Priority Review for Revuforj sNDA

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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.

Nektar Sees Promising Data with Dermatitis Drug

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Nektar Therapeutics reports promising results from a mid-stage clinical trial of its experimental therapy rezpegaldesleukin for pa...

FDA Olympus Scope Import Alerts

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FDA tells healthcare providers to be aware of import alerts for specific Olympus medical devices that are being refused entry into...

Davis Returning to CDER as Deputy Director

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FDA says Usona Institute chief medical officer Michael C. Davis is returning to CDER as the Centers deputy director after being go...