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FDA OKs Updated Dosing for Lillys Alzheimer's Drug

[ Price : $8.95]

FDA approves an updated dosing schedule for Eli Lillys Alzheimers therapy Kisunla (donanemab-azbt) to reduce the risk of a known s...

CGMP, Other Violations at Dynamic Blending

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FDA warns Vineyard, UT-based Dynamic Blending Specialists about multiple violations in its work as a contract manufacturer of over...

Libby Laboratories CGMP Issues

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FDA warns Berkeley, CA-based Libby Laboratories about CGMP violations in its manufacturing of finished drugs.

Device AI Facts Labeling Needed: Paper

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University of Illinois law school scholar Sara Gerke calls for FDA to create AI Facts labeling for artificial intelligence-powered...

New FDA Guide Doesnt Stop Some Device Hacking: Paper

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A Foundation for Defense of Democracies paper calls on FDA to correct a gap in a recent guidance that makes in-use medical devices...

Multiple Insightra Medical Violations Cited

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FDA warns Clarksville, TN-based Insightra Medical about multiple violations in its production of intra-aortic balloon pump cathete...

FDA Study Finds Liver Risks Associated with CBD

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A new FDA clinical trial finds that cannabidiol may cause liver enzyme elevations in otherwise healthy adults raising new concern...

Expanded Parkinsons Use OKd for Insightec Device

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FDA approves an expanded indication for Insightecs Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatme...

Biotech Leaders Support Access to Mifepristone

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A letter from dozens of biotechnology industry executives and investors urges FDA commissioner Marty Makary to reject efforts to r...

FDA Drops REMS Need for ERA Meds

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FDA drops REMS requirements covering embryofetal toxicity risk in endothelin receptor antagonists.