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Beta Bionics Gets Warning on iLet Bionic Pancreas

[ Price : $8.95]

FDA issues Beta Bionics a Warning Letter, citing wide-ranging quality system, complaint handling, reporting, and recall-related vi...

BioMarin Withdrawing Hemophilia A Gene Therapy

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BioMarin decides to voluntarily withdraw from the market its Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating...

AdvaMed Presses FDA to Anchor Federal Strategy on Clinical AI

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AdvaMed urges federal health officials to keep FDA at the center of oversight for artificial intelligence tools used in patient ca...

A.Nelson Warned on GMPs After Inspection

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FDA issues a Warning Letter to A. Nelson & Co. Ltd., citing significant current good manufacturing practice violations and raising...

J&J Files sBLA for Imaavy in Rare Anemia

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Johnson & Johnson files a supplemental BLA seeking approval of Imaavy as a treatment for warm autoimmune hemolytic anemia.

FDA Unveils Plausible Mechanism Framework Guidance

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FDA issues a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized The...

Calquence Combo OKd for Leukemia, Lymphoma

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FDA approves AstraZenecas Calquence (acalabrutinib) for use in combination with AbbVie and Genentechs Venclexta (venetoclax), a ch...

Novo Nordisk Obesity Drug Misses Endpoint

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Novo Nordisk says its experimental obesity drug CagriSema delivered substantial weight loss in a head-to-head late-stage trial but...

Industry Vet Named Head of FDA Digital Health Center

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FDA appointed a veteran artificial intelligence executive to lead its digital health policy unit, signaling a sharper regulatory f...

DTC Scrutiny Accelerating in 2026: Mintz

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A Mintz legal update says FDA appears to be sustaining and in some cases accelerating its scrutiny of prescription drug advertis...