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Human Drugs

Lilly Planning Tirzepatide Submission Soon

Lilly says it expects to make a regulatory submission in the coming weeks for its tirzepatide for weight loss in adults with obesity or overweight wit...

ViiV Dovato Ad Claims Challenged

The Better Business Bureaus National Advertising Division refers to FDA and the Federal Trade Commission for review and possible enforcement action di...

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Drug Supply Chain Independence Bill

Bipartisan legislation is reintroduced in the House that its sponsors say will make the nations pharmaceutical supply chain less dependent on foreign ...

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Medical Devices

Ultromics Gets Breakthrough Status for AI Device

FDA grants Ultromics a breakthrough device designation for its artificial intelligence-supported platform for detecting cardiac amyloidosis.

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Medical Devices

Cybersecurity Alert on Illumina Device Software

FDA issues an alert about a cybersecurity vulnerability affecting the Universal Copy Service software in several Illumina laboratory instruments.

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Human Drugs

FDA Approves Oral Fecal Microbiota Capsules

FDA approves a Seres Therapeutics BLA for Vowst (fecal microbiota spores, live-brpk), an orally administered microbiota-based product to prevent recur...

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Human Drugs

Prevent Makena Compounding: Public Citizen

Public Citizen calls on FDA to promptly add Covis Pharmas Makena to the official list of drugs that have been withdrawn for reasons of safety or effec...

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Federal Register

Info Collection on Animal Drug Reporting

Federal Register notice: FDA sends to OMB an information collection entitled Records and Reports Concerning Experiences with Approved New Animal Drugs...

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Human Drugs

Gillibrand Bill to Speed FDA Approval of Some Drugs

Sen. Kirsten Gillibrand introduces the bipartisan Promising Pathways Act to permit FDA provisional approval of some drugs for life-threatening disease...

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Human Drugs

Quality Management Maturity Dividing Industry: PDA

The Parenteral Drug Association says its members still have many questions about CDERs Quality Management Maturity program and recommendations to impr...