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Human Drugs

FDA Approves Otsuka/Lundbeck Schizophrenia Drug

FDA approves an Otsuka America Pharmaceutical and Lundbeck NDA for Abilify Asimtufii (aripiprazole) a once-every-two-months injection for treating sch...

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FDA Planning TV Ad Endorser Research

The CDER Office of Prescription Drug Promotion says it will research issues involving the use of endorsers in prescription drug TV ads.

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Public Citizen calls on FDA to promptly add Covis Pharmas Makena to the official list of drugs that have been withdrawn for reasons of safety or effec...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