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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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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.

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Human Drugs

FDA Approves BMS Opdivo Qvantig Injection

FDA approves Bristol Myers Squibbs Opdivo Qvantig subcutaneous injection for several cancer indications.

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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.

Human Drugs

Hidden Ingredient in Rhino 11 Gummies: FDA

FDA recommends that consumers not purchase or use Rhino 11 gummies due to the presence of undeclared tadalafil.

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Medical Devices

FDA Alert on Boston Accolade Pacers Early Replacement

FDA alerts patients, caregivers, and healthcare providers to the potential for some Boston Scientific Accolade pacemakers to need replacement early.

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Human Drugs

Axsome Plans Alzheimers NDA on Mixed Data

Axsome Therapeutics plans an NDA submission for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating Alzheimers disease ag...

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Human Drugs

Exclude Liraglutide from Compounding: Novo Nordisk

Novo Nordisk petitions FDA to exclude its liraglutide from the agencys list of bulk drug substances that may be used by drug compounders.