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Trump to Fire Thousands of HHS Workers: Report

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Mainstream media reports based on anonymous sources say the White House is preparing an order to require HHS to fire a percentage ...

Cancer Drug Tabloid ANDA Restrictions Sought

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A Buchanan Ingersoll petition asks FDA to maintain restrictions on cancer drug Tabloid ANDAs that are in the applicable product-sp...

Fast Track Status for Crohns Imaging Agent

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FDA grants Bracco Imaging a fast-track designation for its BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injecti...

Diabetes Device Smartphone Alerts Malfunctioning: FDA

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An FDA safety alert on certain diabetes devices that rely on a smartphone to deliver critical safety alerts warns that these may m...

More States Want to Import Drugs: Bloomberg

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A Bloomberg Law report says New York is the latest state to indicate an interest in the FDA pathway to import lower-cost drugs fro...

Ziftomenib NDA Due in 2nd Quarter: Kura/Kyowa

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Kura Oncology and Kyowa Kurin say they expect to submit a ziftomenib NDA to FDA in the second quarter of 2025.

Breakthrough Status for ACR-368 OncoSignature Assay

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FDA grants Acrivon Therapeutics a breakthrough device designation for the ACR-368 OncoSignature assay, a multiplex immunofluoresce...

Baxter Recalls Life2000 Ventilators

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Baxter Healthcare Corporation recalls its Life2000 Ventilator System due to a nonconforming battery charger.

Monlunabant Trial Misses End Point in Kidney Trial

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Novo Nordisk says a recent Phase 2 trial of monlunabant in diabetic kidney disease patients failed to meet its primary endpoint.

CGMP Violations in Imperial Palace Records

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FDA warns Chinas Imperial Palace Commodity about CGMP violations in its manufacturing of over-the-counter drugs.