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FDA Accepts Resubmission of Biologics License Application for Sacituzumab Govitecan

Earlier today the U.S. Food and Drug Administration (FDA) confirmed that it has accepted Immunomedics' Resubmission of the Biologics License Application (BLA) for sacituzumab...

Seattle Genetics Submits Supplemental Biologics License Application Brentuximab Vedotin in Cutaneous...

Seattle Genetics has submitted a supplemental Biologics License Application or BLA to the U.S. Food and Drug Administration (FDA) for brentuximab vedotin (Adcetris®) for...

Evolving CMC Analytical Techniques for Biopharmaceuticals

1.0 Abstract During the (early) preclinical drug development process as well as manufacturing of biopharmaceutical (protein) products, analysis and characterization are crucial in gaining a...