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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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Human Drugs

Guide on Drug Batch Uniformity and Integrity

FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch uniformity and drug produ...

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Federal Register

Guide on Advanced Manufacturing Tech

Federal Register notice: FDA makes available a final guidance entitled Advanced Manufacturing Technologies (AMT) Designation Program.

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Human Drugs

Chimerix NDA for Glioma Drug

Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma.