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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.

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Human Drugs

Bhargava Phytolab CGMP Violations

FDA warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients.

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Human Drugs

FDA Wants Labeling Changes for Buprenorphine

FDA recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to indicate there is no...

Human Drugs

FDA Approves Neurocrines Crenessity for CAH

FDA approves Neurocrine Biosciences Crenessity to be used with glucocorticoids to control androgen in adult and some pediatric patients with classic c...

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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.