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Human Drugs

FDA Warns 4 Online GLP-1 Sellers

FDA warns four companies it says are marketing unapproved copies of popular weight loss drugs.

Medical Devices

Global Unique Device ID Database Guidance

FDA publishes an updated Global Unique Device Identification Database guidance.

Human Drugs

Hikma Victoza Generic Approved by FDA

FDA approves Hikmas liraglutide injection, the first generic form of Novo Nordisks Victoza it has approved.

Human Drugs

Rhythm Gets Expanded Imcivree Indication

FDA approves an expanded indication for Rhythms Imcivree to include pediatric patients as young as age 2.

Human Drugs

Ionis Pharmaceuticals Tryngolza Approved for FCS

FDA approves Ionis Tryngolza as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.

Animal Drugs

Canine Librela Adverse Events Analyzed: CVM

FDA says it has completed its evaluation of several adverse effects found in dogs treated with Librela for pain associated with osteoarthritis.

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Human Drugs

CGMP Violations in Micro Orgo Chem Inspection

FDA warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.

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FDA General

Temple Retires; Bumpus Leaves FDA

CDER senior advisor for clinical science Bob Temple retires, and FDA principal deputy commissioner Namandj Bumpus leaves the agency ahead of the new i...

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Biologics

Xbrane Refiles Lucentis Biosimilar BLA

Xbrane Biopharma refiles a BLA for its investigational ranibizumab, a biosimilar copy of Genentechs age-related macular degeneration drug Lucentis.

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Medical Devices

Alert on AquaFlexFlow Blood Circuits

FDA issues a safety alert on Nuwellis AquaFlexFlow UF 500 Plus extracorporeal blood circuit because the device may trigger a weight mismatch alarm whi...