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Human Drugs

House Committee Advances FDA Budget Bill

The U.S. House Appropriations Committee advances in a 35 to 27 vote FDAs fiscal year 2026 spending bill.

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Medical Devices

Safety Alert on Medtronic Esophagus pH Monitor

FDA posts a safety alert on Medtronic subsidiary Given Imaging and certain Bravo CF Capsule delivery devices, which are designed to monitor pH in a pa...

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Human Drugs

Safety Communication on 2 Elevidys-related Deaths

FDA issues a safety communication about two reports of fatal acute liver failure following treatment of Duchenne Muscular Dystrophy patients with Sare...

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Human Drugs

Nektar Sees Promising Data with Dermatitis Drug

Nektar Therapeutics reports promising results from a mid-stage clinical trial of its experimental therapy rezpegaldesleukin for patients with moderate...

Medical Devices

FDA Olympus Scope Import Alerts

FDA tells healthcare providers to be aware of import alerts for specific Olympus medical devices that are being refused entry into the U.S. due to ong...

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Human Drugs

Davis Returning to CDER as Deputy Director

FDA says Usona Institute chief medical officer Michael C. Davis is returning to CDER as the Centers deputy director after being gone two and a half ye...

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Human Drugs

CGMP Issues in Pushclean Records Review

FDA warns Turkeys Pushclean Technology about CGMP violations in its manufacturing of over-the-counter drug products.

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Medical Devices

QS, MDR Violations at S. Koreas Aju Pharm

FDA warns South Koreas Aju Pharm about QS and MDR violations in its production of two Class 2 medical devices.

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Biologics

FDA Skips Panel Review for Capricor Cell Therapy

FDA says there will be no advisory committee review of Capricor Therapeutics BLA for Deramiocel, the companys lead cell therapy candidate for treating...

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Human Drugs

CDER Acting Head Corrigan-Curay Leaving in July

CDER acting director Jacqueline Corrigan-Curay decides to retire and will leave her post next month.