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REMS Requirements Ended for CAR T Cell Therapies

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FDA removes risk evaluation and mitigation strategies requirements for all currently approved CAR T cell therapies, saying the pro...

UCB Positive Data for Epileptic Encephalopathy Drug

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UCB reports positive data from a Phase 3 clinical trial evaluating fenfluramine as an adjunctive treatment for rare epileptic ence...

Appeals Court Backs FDAs Sameness Interpretation

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An appeals court rules for FDA that a clinically superior drug is not the same as a drug that is otherwise the same.

NDA Filed for Nicotine Dependence Drug

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Achieve Life Sciences files an NDA for cytisinicline for treating nicotine dependence as part of smoking cessation in adults.

Livmarli, Bylvay Get Liver Injury/Bleeding Updates

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FDA issues safety-related labeling updates for two bile acid transport inhibitors Mirum Pharmaceuticals Livmarli and Ipsen Biopha...

Antibacterial Therapies Development Q&A Guidance

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FDA publishes a question-and-answer guidance to help sponsors develop new antibacterial drugs.

Altimmune Mixed Results for Pemvidutide in MASH

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Altimmune reports mixed topline results today from its Phase 2b IMPACT trial evaluating pemvidutide in patients with metabolic dys...

UDI Requirements for Combo Products Guide

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FDA posts a draft guidance entitled Unique Device Identifier (UDI) Requirements for Combination Products.

Marks: Why Dramatic Departure from Vaccine Policy?

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Former CBER director Peter Marks says FDA should explain why it changed its Covid-19 vaccine policy in a way that did not promote ...

Remote Regulatory Assessment Q&A Guidance

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FDA publishes a guidance with questions and answers on its various remote regulatory assessment tools.