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Human Drugs

NECC Co-owner Sentenced to 1 Year Jail Term

A Boston federal judge sentences former co-owner of now-closed New England Compounding Center, Gregory Conigliaro, to one year in prison for his role ...

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FDA General

Biden Signs Medical Marijuana/Cannabidiol Research Law

President Biden signs into law HR 8454, the Medical Marijuana and Cannabidiol Research Expansion Act.

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Biologics

FDA Rejects Y-mAbs BLA for Brain Condition

FDA sends Y-mAbs Therapeutics a complete response letter on its BLA for I-omburtamab and its use in treating CNS/leptomeningeal metastasis from neurob...

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Human Drugs

FDA Lifts Hold on Leukemia/Lymphoma Therapy

FDA lifts a clinical hold against Beam Therapeutics and its BEAM-201 for treating relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymph...

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Medical Devices

FDA Hits Cutera With Warning on Web Site Promo

FDA sends Cutera a Warning Letter related to marketing material that appeared on a company owned Web site about uncleared gynecological indications, i...

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Medical Devices

Medtronic HeartWare Dear Doctor Letter

A Medtronic Dear Doctor letter describes a potential issue with the driveline cover in its HeartWare Ventricular Assist Device.

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Human Drugs

Lillys Donanemab Tops Aduhelm in Study

Lilly says its investigational Alzheimers drug donanemab outperformed Biogens Aduhelm in clearing brain amyloid in a Phase 3 comparator study.

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Human Drugs

Innoviva Files NDA for Sul-Dur Antibiotic

FDA accepts for priority review an Innoviva NDA for intravenous Sul-Dur (sulbactam and durlobactam) for treating infections caused by Acinetobacter b...

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Human Drugs

Argenx Buys Priority Review Voucher from Bluebird for $102 Mil.

Argenx pruchases a Priority Review Voucher from Bluebird Bio for $102 million, which Argenx plans to use for a planned BLA for efgartigimod, which it ...

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Human Drugs

Act on Orphan Drug Exclusivity: Attorney

Mayer Brown attorney George OBrien calls on FDA to take steps to respond to a 2021 11th Circuit Court of Appeals decision throwing out the agencys ind...