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Fresenius Recalls Infusion Pump Software

[ Price : $8.95]

Fresenius Kabi USA recalls (Class 1) its large-volume pump software of the Ivenix Infusion System due to software anomalies that h...

Sun Gets OAI Inspection at India Facility

[ Price : $8.95]

FDA classifies a December inspection at Sun Pharmaceutical Industries Dadra, India facility as official action indicated.

Panel Backs Minimal Residual Disease Endpoint

[ Price : $8.95]

FDAs Oncologic Drugs Advisory Committee unanimously votes (12 to 0) that the totality of data are adequate to support the use of m...

Enlivex Mixed Results of Sepsis Cell Therapy

[ Price : $8.95]

Enlivex Therapeutics reports mixed results from its Phase 2 study of Allocetra in patients with sepsis.

PureTech Gets Fast Track on LYT-200

[ Price : $8.95]

FDA grants PureTech Health a fast-track designation for LYT-200 in combination with anti-PD1 therapy for treating recurrent/metast...

AI Software Authorized for Osteoporosis Screens

[ Price : $8.95]

FDA grants 16 Bit Inc. a de novo marketing authorization for Rho, an AI-enabled software device aimed at improving osteoporosis sc...

EMA Committee Dismisses GLP-1 Suicidality Risk

[ Price : $8.95]

As FDA continues to evaluate the risk of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists...

FDA Updates Safety Labeling for Envarsus XR

[ Price : $8.95]

FDA approves new safety labeling for Veloxis Pharmaceuticals Envarsus XR (tacrolimus), indicated for use with other medicines to h...

9 Applicants Chosen for Drug Quality Evaluation

[ Price : $8.95]

FDAer Susan Rosencrance tells the agencys Generic Drug Forum that FDA has chosen nine applicants to participate in a Quality Matur...

Kemstro Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that UCBs Kemstro (baclofen) orally disintegrating tablets, 10 mg and 20 mg, were not with...