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Australia Regulatory Authority Declines Approval of Eisai’s Lecanemab for Early Alzheimer’s Disease

March 11th 2025

The Therapeutic Goods Administration (TGA) of Australia confirmed its initial decision to decline approval of the mAb for treating early Alzheimer’s disease.

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EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC

March 10th 2025

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EMA Approves TAKHZYRO for Additional Subcutaneous Administration Option to Treat Hereditary Angioedema

March 7th 2025

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Symbiosis Reports Successful Completion of FDA Inspection of Scotland Facilities

March 6th 2025

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Design Quality in Pharmaceutical Design: A Primer for Facility Executives

March 5th 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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