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Human Drugs

KVK Paying $3.5 Million in Guilty Plea

KVK Research and KVK Tech of Bucks County, PA, plead guilty to introducing adulterated drugs into interstate commerce and agree to pay a $1.5 million ...

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Human Drugs

Positive Phase 1 Data on New Novo Weight-Loss Drug

Novo Nordisk says its experimental weight-loss pill amycretin achieved a 13.1% weight loss in participants in a Phase 1 trial.

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Human Drugs

Accelerated Approval for Brukinsa for Some Lymphomas

FDA grants accelerated approval for BeiGenes Brukinsa used with Genentechs Gazyva to treat some follicular lymphomas.

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Human Drugs

Alliance for Regenerative Medicine AMT Concerns

The Alliance for Regenerative Medicine raises concerns about an FDA draft guidance on alternative manufacturing technologies.

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Human Drugs

Opdivo Approved in First-Line Bladder Cancer

FDA approves Bristol Myers Squibbs Opdivo (nivolumab) for combination use with cisplatin and gemcitabine for first-line treatment of adult patients wi...

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6 Reps Want FDA Voucher for Valley Fever

Five House Republicans and one Democrat from Arizona and California call on FDA to add Valley Fever to the list of tropical diseases eligible for the ...

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Medical Devices

Medtronic Class 1 Recall of Duet Drainage Device

FDA classifies as Class 1 a Medtronic Neurology recall of its Duet External Drainage and Monitoring System due to the potential for catheter disconnec...

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Federal Register

2 ICH Analytical Procedure Guides Available

Federal Register notice: FDA makes available two International Council for Harmonization final guidances entitled Q2(R2) Validation of Analytical Proc...

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Federal Register

Gastrointestinal Drugs Committee Renewal

Federal Register notice: FDA renews its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter expiration date.

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Medical Devices

Ventec Life Recalls VOCSN Breathing Package

Ventec Life Systems recalls its VOCSN Patient Breathing Package due to a manufacturing issue that causes the bonded spiral wrap to detach before or du...