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Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval

This study aims to determine whether cancer drugs granted accelerated approval from the US Food and Drug Administration ultimately demonstrate clinical ....

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FDA Grants Full Approval to Blinatumomab for MRD+ B-cell Precursor ALL

The FDA has granted regular approval to blinatumomab (Blincyto) for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease of at least 0.1% ....

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Erste Vollzulassung: Reguläre Zulassung für Comirnaty in den USA

Erste Vollzulassung: Reguläre Zulassung für Comirnaty in den USA
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