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FDA Alert on Baxters Infusion Pump

[ Price : $8.95]

FDA issues an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume infusion pump.

Official Action Indicated Rare in GCP Inspections: Report

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FDA researchers analyze the results of good clinical practice inspections from 2017 to 2023, finding that less than 1% resulted in...

FDA: Multiple Violations at O3UV

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FDA warns Grand Ledge, MI-based O3UV about multiple CGMP violations in its illegal production of autohemotherapy devices.

CGMP Violations at Glenmark Unit

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FDA warns Indias Glenmark Pharmaceuticals about CGMP violations in the production of finished drugs at one of its manufacturing fa...

FDA Rejects Replimune BLA for Melanoma Therapy

[ Price : $8.95]

FDA rejects a Replimune priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec).

FDA Wins as Sarepta Folds and Stops Shipping Elevidys

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FDA wins the latest round in its regulatory battle against gene therapy maker Sarepta Therapeutics after the company agrees to sto...

Lax GLP-1 Compounding Regulation Hurts Patients: Report

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Center for Medicine in the Public Interest president Peter Pitts says FDA must protect patients by tightening its regulation of co...

Laura Loomer Urges Ouster of CBER Head Prasad

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Conspiracy theorist and Trump confidant Laura Loomer urges the firing of CBER director Vinay Prasad due to his previous anti-Trump...

Maquet Servo Ventilators in Class 1 Recall

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Maquet Critical Care recalls (Class 1) its Servo Ventilator Systems to update their use instructions due to the risk of inaccurate...

J&J Seeks Approval for Oral Peptide for Psoriasis

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Johnson & Johnson files an NDA for icotrokinra, which it describes as a first-in-class oral therapy for moderate to severe plaque ...