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FDA Appoints New Director of CBER

May 7th 2025

Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.

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Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing

May 7th 2025

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Complying with European versus US GMPs

May 2nd 2025

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Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC

April 29th 2025

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MHRA Approves GSK Therapy Combinations for Multiple Myeloma

April 21st 2025

Digitalization of QbD Risk Assessments

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

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