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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.

Human Drugs

FDA Approves Novo Hemophilia Prophylaxis Drug

FDA approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.

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Human Drugs

New Sleep Apnea Indication for Lillys Zepbound

FDA approves a new indication for Lillys Zepbound to treat some obese patients with obstructive sleep apnea.

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Human Drugs

Astellas Recalls Lots of Prograf and Astagraf

FDA says Astellas has recalled one lot each of its Prograf and Astagraf transplant medications that may contain empty capsules.

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Medical Devices

QS, MDR Violations at Rontis Hellas in Greece

FDA warns Greeces Rontis Hellas about Quality System and Medical Device Reporting violations in its production of a balloon catheter.