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Medical Devices

GE Recalls Carestation Anesthesia Devices

GE HealthCare recalls certain Carestation anesthesia devices due to the risk that they may not provide effective ventilation in certain situations.

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Human Drugs

Bimagrumab Enhances Weight Loss: Study

New data from a Phase 2 study on Eli Lillys experimental bimagrumab showed that when combined with Novo Nordisk's Wegovy (semaglutide) it led to prese...

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Human Drugs

Guideline on Drug Stability Testing Released

FDA posts an International Council for Harmonization draft guideline entitled Stability Testing of Drug Substances and Drug Products Q1.

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Human Drugs

Inspections Help Prevent Drug Shortages: Study

A new study disputes previous assumptions about FDA inspections leading to more drug shortages at facilities receiving GMP citations.

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Human Drugs

Daiichi Sankyo Drug OKd for Lung Cancer

FDA approves a Daiichi Sankyo BLA for Datroway (datopotamab deruxtecan-dlnk) for certain adults with locally advanced or metastatic epidermal growth f...

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Human Drugs

Medline Issues Correction for Procedure Kits

Medline Industries recalls certain lots of its medical procedure kits that include recalled Medtronic Aortic Root Cannulas due to a potential safety r...

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Human Drugs

Dupixent Approved for Bullous Pemphigoid

FDA has approved Sanofi and Regenerons Dupixent (dupilumab) for treating adult patients with bullous pemphigoid that mainly affects the elderly with i...

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Human Drugs

Monjuvi Approved for Follicular Lymphoma

FDA approves Incytes Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for treating adults with relapsed or refractory follicu...

Medical Devices

FDA Clears DeepEcho AI Fetal Ultrasound

FDA clears a DeepEcho 510(k) for its artificial intelligence-based fetal ultrasound analysis platform.

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Human Drugs

Cycles Harliku Approved for Alkaptonuria

FDA approves a Cycle Pharmaceuticals NDA for Harliku (nitisinone) tablets for reducing urine homogentisic acid in adult patients with alkaptonuria.