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Strukmyer Medical CGMP Violations

[ Price : $8.95]

FDA warns Mesquite, TX-based Strukmyer Medical about CGMP violations in manufacturing finished drugs and cosmetics.

Chengdu Records Review Finds CGMP Deviations

[ Price : $8.95]

FDA warns Chinas Chengdu Innovation Pharmaceutical Co. about CGMP deviations in manufacturing active pharmaceutical ingredients.

Court Orders FDA to Restore Gender Web Pages

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DC federal judge John Bates orders FDA and CDC to re-post Web pages and datasets they removed to comply with President Trumps exec...

Change FDA Approach to Antibiotic Approval: Column

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A STAT First Opinion column calls on FDA to focus on how effective new antibiotics are in real-world patients, rather than approvi...

Biohaven NDA Filed for Spinocerebellar Ataxia Drug

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FDA accepts for priority review a Biohaven NDA for troriluzole for treating adult patients with spinocerebellar ataxia.

Breakthrough Status for Knee Arthritis Device

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FDA grants Guerbet a Breakthrough Device Designation for LipioJoint, a liquid embolic agent designed to alleviate pain in patients...

SpringWorks Gomekli Approved for Neurofibromatosis

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FDA approves a SpringWorks Therapeutics NDA for Gomekli (mirdametinib) for treating certain patients with neurofibromatosis Type 1...

CA Man Sentenced Over Unapproved Drugs

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FDA says Jeremy Brown of Simi Valley, CA has been sentenced for introducing unapproved drugs into interstate commerce.

Sentec/Percussionaire Breathing Circuit Recalled

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Sentec/Percussionaire recalls its Phasitron breathing circuit kits after receiving a complaint that the venturi component of the k...

Pliant Pauses Bexotegrast Trial for Safety Review

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Pliant Therapeutics pauses enrollment and dosing due to an undisclosed safety concern in its ongoing BEACON-IPF Phase 2b trial of ...