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Baxter Recalls Life2000 Ventilators Over Cybersecurity Risks

[ Price : $8.95]

Baxter recalls (Class 1) its Life2000 Ventilation System after the company discovered a cybersecurity vulnerability.

Quality System Violations at Hong Qiangxing Electronics

[ Price : $8.95]

FDA warns Chinas Hong Qiangxing Shenzhen Electronics about Quality System violations in its production of several medical devices....

Owen Biosciences CGMP Violations

[ Price : $8.95]

FDA warns Baton Rouge, LA-based Owen Biosciences about CGMP violations in its production of finished drugs as a contract manufactu...

Gene Therapy for Broader Spinal Muscular Atrophy Range

[ Price : $8.95]

FDA approves Novartis Itvisma (onasemnogene abeparvovec-brve), a new formulation of a gene therapy for a broader age of spinal mus...

Guidance on Where to Submit Cross-Center Master Files

[ Price : $8.95]

FDA issues a draft guidance with recommendations to help master file holders determine to which Center to submit cross-Center mast...

Makary Missing the Point on Advisory Committees: Zuckerman

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National Center for Health Research president Diana Zuckerman defends FDA advisory committees, saying they do a more thorough job ...

Amycretin Sees 14.5% Weight Loss in Phase 2 Diabetes Trial

[ Price : $8.95]

Novo Nordisk reports favorable Phase 2 data for its investigational dual-action obesity and diabetes drug amycretin, showing signi...

Study Finds Public Speaker Conflicts at FDA Panel Meetings

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A new study of FDA advisory committee meetings reveals that a substantial portion of public speakers support drug approval, and ma...

Catalent Indiana FDA-483 Has Six Observations

[ Price : $8.95]

FDA releases the form FDA-483 with six observations from an inspection at the Catalent Indiana sterile drug manufacturing facility...

FDA Flags Misleading Promotion of Generic Ketamine Drug

[ Price : $8.95]

FDA cites PharmaTher over alleged misleading promotional claims for its generic ketamine.