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Biologics

FDA Approves Expanded Abrysvo Indication

FDA approves an expanded indication for Pfizers Abrysvo RSV vaccine to include adults from age 18 and up.

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Human Drugs

CA Man Pleads Guilty to Selling Unapproved Drugs

A California man operating a company called Warrior Labz SARMs pleads guilty to selling unapproved drugs after receiving an FDA Warning Letter advisin...

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Human Drugs

U.P. Oncolytics Gets Orphan Status for Glioma Therapy

FDA awards U.P. Oncolytics an orphan drug designation for its oncolytic virus-based therapy to treat malignant gliomas.

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Marketing

FDA to Study Adherence and Patient Preference in Ads

FDA says the CDER Office of Prescription Drug Promotion will research how consumers and primary care physicians respond to drug ads containing informa...

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AI Forcing FDA to Rethink Everything: Califf

FDA commissioner Robert Califf says the agency is being forced by artificial intelligence to rethink how it conducts business.

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Human Drugs

Issues Found in BIMO Clinical Site Inspection

FDA warns Orange, CA-based neurologist Namita Goyal about violations found in a bioresearch monitoring inspection of a clinical trial she conducted.

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Amnio Technology Illegally Marketing Amniotic Products: FDA

FDA warns Phoenix, AZ-based Amnio Technology it is illegally manufacturing and distributing amniotic membrane and fluid products that have significant...

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Human Drugs

Otsuka Reports Interim Data on Sibeprenlimab

Otsuka reports positive topline interim data from an ongoing Phase 3 clinical trial of sibeprenlimab and its use for treating immunoglobulin A nephrop...

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Human Drugs

Acromegaly NDA Hit with Complete Response Letter

FDA sends Camurus a complete response letter on its NDA for CAM2029 (octreotide) extended-release injection and its use in treating patients with acro...

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Federal Register

Comments Extended for Chemical Analysis Device Guide

Federal Register notice: FDA extends the comment period for a 9/20 notice on a draft guidance entitled Chemical Analysis for Biocompatibility Assessme...