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Human Drugs

FDA OKs Arrays Braftovi for Some Cancers

FDA approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.

Human Drugs

FDA OKs Galderma Dermatitis Drug Nemluvio

FDA approves Galdermas Nemluvio to treat some dermatitis patients aged 12 and older.

Human Drugs

Alcon Recalls Systane Ultra PF Eye Drops

FDA says Alcon recalled one lot of Systane Ultra PF eye drops due to potential fungal contamination.

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.

Human Drugs

Endo Recalls Adrenalin Chloride Solution

FDA says Endo USA has recalled its Adrenalin Chloride Solution that predates the Federal Food, Drug, and Cosmetic Act and was never submitted for FDA ...

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.