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U.P. Oncolytics Gets Orphan Status for Glioma Therapy

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

FDA to Study Adherence and Patient Preference in Ads

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

AI Forcing FDA to Rethink Everything: Califf

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

Issues Found in BIMO Clinical Site Inspection

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

Amnio Technology Illegally Marketing Amniotic Products: FDA

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

Otsuka Reports Interim Data on Sibeprenlimab

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

Acromegaly NDA Hit with Complete Response Letter

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

Comments Extended for Chemical Analysis Device Guide

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Federal Register notice: FDA extends the comment period for a 9/20 notice on a draft guidance entitled Chemical Analysis for Bioco...

Drug Interaction Labeling Guidance

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FDA publishes a draft guidance with recommendations for the placement and content of drug interaction information in labeling for ...

Sangamo to Seek Accelerated OK on Gene Therapy

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Sangamo Therapeutics reaches an agreement with FDA on a clear regulatory pathway to accelerated approval for the companys gene the...