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FDA Updates Guidance on Choosing Between ANDA and 505(b)(2) Pathways

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FDA posts a draft revised guidance intended to help drug developers determine whether a proposed product should be submitted throu...

Europe Rules Against Amgens Tavneos Marketing Authorization

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While Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., European regulators have recommended th...

Regeneron Halts Phase 1/2a Eye Disease Trial Due to Safety Review

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Regeneron Pharmaceuticals stops a Phase 1/2a clinical trial of experimental anti-CD3 monoclonal antibody REGN7041 in patients with...

Senators Release 2021 Woodcock Email on Covid-19 Concern

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Sens. Ron Johnson (R-WI) and Rand Paul (R-KY) release a 2021 email from then-acting FDA commissioner Janet Woodcock in which she r...

Public Meeting on Opioid Medication Use

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FDA plans a 9/9 meeting with the Reagan-Udall Foundation for the agency to hear public comments on perspectives involving opioid m...

Valisure Sues USP Over Criticism of Drug-Testing Methods

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Valisure files a lawsuit against the United States Pharmacopeia, accusing the standards-setting organization of making false and m...

Baxter Recalls Duo-Vent Solution Sets Over Air Embolism Risk

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Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may allow air bubbles to enter the ad...

FDA OKs Lantheus Tau PET Imaging Agent for Alzheimers Disease

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FDA approves Lantheus Holdings Tauklarify (florquinitau F 18 injection) as a PET imaging agent to identify tau neurofibrillary tan...

FDA Meeting to Review Survival Data for Osteosarcoma Therapy

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FDA grants OS Therapies a Type C statistical methods meeting with CBER to discuss 2.5-year overall survival data for OST-HER2, the...

Replimune Approval Document Highlights Reviewer Objections

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An FDA approval document shows that the accelerated approval of Replimunes Tudriqev came despite significant concerns about the re...