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FDA Enforcement Year in Review

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A Ropes & Gray year-end review examines significant changes in FDA and Justice Department enforcement actions pertaining to regula...

FDA Lifts Clinical Hold on Intellias Phase 3 Trial

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FDA lifts a clinical hold on Intellia Therapeutics MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran for patients with her...

Warning Letter Issued to Meridian Bioscience

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FDA sends a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manu...

FDA Warns MAST Biosurgery Over Manufacturing Violations

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FDA issues MAST Biosurgery a Warning Letter after an August inspection cited serious manufacturing quality and safety reporting vi...

Scancell Advancing iSCIB1+ Into Phase 3 Melanoma Trial

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FDA approves a Scancell Holdings IND to begin a registrational Phase 3 trial of iSCIB1+ in patients with advanced melanoma.

Former CytoDyn CEO Sentenced to Prison

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A federal judge sentences former CytoDyn chief executive Nader Pourhassan to 30 months in prison for misleading investors about th...

Plausible Mechanism Drug Pathway Raises Process Concerns

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A Health Affairs analysis on FDAs new pathway allowing drug approvals based on a plausible mechanism of action warns that the appr...

Sarepta Reports Positive Data on Duchenne Gene Therapy

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Sarepta Therapeutics announces that its gene therapy Elevidys significantly slowed disease progression over three years in ambulat...

Advocacy Push Precedes FDA Meeting on Stalled Gene Therapy

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AMT-130 is a gene therapy designed to lower levels of the mutant huntingtin protein believed to drive Huntingtons disease progress...

Symposium on Clinical Trials, Bioequivalence and Pharmacovigilance

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U.S., U.K. and Canadian drug regulators announce a joint international symposium to discuss evolving regulatory expectations for c...