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Merus Bizengri Wins Accelerated Approval

[ Price : $8.95]

FDA grants Merus accelerated approval for Bizengri (zenocutuzumab-zbco) for certain adults with advanced, unresectable, or metasta...

Drug-Induced Liver Injury Indicator Seen: FDA

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FDAs National Center for Toxicological Research finds a new predictor for drug-induced liver injury.

CGMP Violations at Zhejiang Uniquality

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FDA warns Chinas YouQuan Care Products about CGMP violations in its manufacturing of finished drugs.

Roivant Scraps Sarcoidosis Drug After Failed Trial

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Roivants Kinevant Sciences unit halts the development of namilumab for treating sarcoidosis after a Phase 2 study failed to show t...

FDA 2024 Guidance Report and Best Practices

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FDA issues a report and plan on best practices for guidances, incorporating comments from a 2023 draft report and plan.

Predetermined Change Control Plan Guide

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FDA publishes a guidance with recommendations for marketing submissions for Predetermined Change Control Plans for artificial inte...

Multiple Violations at S. Koreas LCC Ltd.

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FDA warns South Koreas LCC Ltd. about CGMP violations in its manufacturing of unapproved and misbranded over-the-counter drugs.

Merck Breakthrough Status for Lung Cancer Drug

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FDA grants Merck a breakthrough therapy designation for sacituzumab tirumotecan (sac-TMT) and its use in treating certain patients...

House Covid Report Hits FDA, Others

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The House Select Subcommittee on the Coronavirus Pandemic faults many FDA actions and decisions in its 550-page report on lessons ...

Applied Therapeutics Faulted for Trial Conduct

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FDA warns New York, NY-based Applied Therapeutics about violations in its conduct of a clinical trial.