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Bayer NDA Accepted for Next-Gen Contrast Agent

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FDA accepts Bayers NDA for gadoquatrane, a next-generation gadolinium-based contrast agent for use in magnetic resonance imaging.

Sen. Cassidy Seeks Postponement of Vaccine Panel

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In the wake of CDC director Susan Monarezs firing, Senate HELP Committee chair Bill Cassidy (R-LA) calls on HHS to postpone a just...

FDA Recommends More Leqembi MRIs

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FDA says it is requiring a change in labeling for Eisai/Biogens Alzheimers drug Leqembi to call for an earlier MRI monitoring scan...

FDA-483 on IntegraDose Inspection

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FDA releases the form FDA-483 with six observations from an inspection at the Minneapolis, MN-based IntegraDose Compounding Servic...

Integra Recalls Surgical Applicators Over Sterility Issues

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Integra LifeSciences recalls (Class 1) its Extended Tip Applicators due to sterility concerns.

Platinum Biologics Selling Unapproved New Drugs: FDA

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FDA warns Orlando, FL-based Platinum Biologics that it is illegally marketing unapproved new drugs.

Hikma Injectables FDA-483 Out

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FDA releases the form FDA-483 with four observations from an inspection at the Dayton, NJ-based Hikma Injectables USA outsourcing ...

Researchers Affirm Mifepristone Safety to FDA

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More than 260 reproductive health researchers urge FDA to continue to support mifepristone based on its 25-year record of safety a...

FDA Looking at MASH Surrogate

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FDA says it has accepted an Echosens Letter of Intent to develop Liver Stiffness Measurement by Vibration-Controlled Transient Ela...

Grace Therapeutics NDA for Hemorrhage Drug Submitted

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FDA accepts for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subar...