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FDA Revokes 2 No-Longer Used Covid Tests

[ Price : $8.95]

Federal Register notice: FDA revokes the Emergency Use Authorizations issued to LifeHope Labs for the LifeHope 2019-nCoV Real-Time...

Guide on Foreign Supplier Program

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Federal Register notice: FDA makes available a final guidance entitled Current Good Manufacturing Practice and Preventive Controls...

Complete Response on Fasenra Supplemental BLA

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FDA sends AstraZeneca a complete response letter on its supplemental BLA for Fasenra (benralizumab) for patients with inadequately...

GE Reagent Not Withdrawn for Safety/Efficacy

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Federal Register notice: FDA determines that GE Healthcares MPI DMSA kidney reagent (Technetium Tc-99m Succimer Kit), Injectable, ...

Baxter Class 1 Recall on Sigma Infusion Pumps

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FDA classifies as Class 1 a Baxter Healthcare recall of its Sigma Spectrum Infusion Pumps with Master Drug Library (Version 8) and...

Incyte Review Extension on Opzelura Cream

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FDA extends by three months its review of Incytes supplemental NDA for Opzelura (ruxolitinib) cream for treating vitiligo.

Warning on Apyx Medicals Renuvion Device

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FDA warns against using Apyx Medicals Renuvion/J-Plasma device for certain aesthetic procedures, such as those intended to improve...

Lynparza Approved for Certain Early Breast Cancer

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FDA approves AstraZenecas Lynparza (olaparib) for the adjuvant treatment of adult patients with deleterious or suspected deleterio...

Philips Hit With Rare 518(a) Order on Ventilators

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After determining inadequate recall notifications to date, FDA issues a rare Section 518(a) notification order to Philips Respiron...

Hold Lifted on Immunome Covid Antibody Cocktail

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FDA removes an Immunome clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19 after the company provided more ...