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uniQure Reports Favorable Data in Huntingtons Trial

[ Price : $8.95]

uniQure reports favorable data on its investigational gene therapy AMT-130 in Huntingtons disease patients.

University of Texas Clinical Trial Issues

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FDA warns Dr. Ralph DeFronzo about violations in his work as a clinical investigator for two trial protocols at the University of ...

Harmony Reports Disappointing Fragile X Data

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Harmony Biosciences reports topline results from a Phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome did not m...

Cell/Gene Therapy Postapproval Monitoring Guide

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FDA posts a draft guidance outlining methods drugmakers should use to collect long-term safety and efficacy data once cell and gen...

CGMP Violations at Janssen Vaccines S. Korea Plant

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FDA warns Janssen Vaccines about CGMP violations in its Incheon, South Korea, drug manufacturing facility.

CGMP Deviations in Chengdu Records Review

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FDA warns Sichuan, China-based Chengdu Brilliant Biopharmaceutical Co. about CGMP deviations in its manufacturing of active pharma...

FDA Issues Complete Response Letter for Apitegromab

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FDA issues Scholar Rock a complete response letter for its BLA seeking approval of apitegromab, indicated for treating spinal musc...

Computer Software Assurance Guidance

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FDA publishes a guidance with recommendations for computer software assurance in computers and automated data processing systems i...

2 Items on Genzyme Ireland FDA-483

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FDA releases the form FDA-483 with two observations from an inspection at the Genzyme Ireland drug manufacturing facility in Water...

Cohance Lifescience FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with six observations from an inspection at the Cohance Lifesciences drug manufacturing facility in ...