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Tag: FDA Breakthrough Therapy Designation

Daiichi Sankyo

Daiichi Sankyo Accelerates BLA Submission for [Fam-] Trastuzumab Deruxtecan in HER2...

Earlier this week Daiichi Sankyo announced plans to accelerate filing of their Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA)...

Supplemental Biologics License Application for Brentuximab Vedotin in Frontline Advanced Hodgkin...

Based on positive results from the Phase III ECHELON-1 Clinical Trial evaluating brentuximab vedotin (Adcetris®; Seattle Genetics) in combination with chemotherapy for the frontline...