FDA grants accelerated approval to zenocutuzumab-zbco for NSCLC and pancreatic adenocarcinoma

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FDA has granted accelerated approval to zenocutuzumab-zbco (Bizengri) for adults with the following:

advanced, unresectable, or metastatic non-small cell lung cancer harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy, oradvanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.

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George F. Tidmarsh has resigned from his job as director of the FDA Center for Drug Evaluation and Research in the aftermath of a lawsuit by a former associate and a probe into what an HHS spokesperson described as “serious concerns about his personal conduct.”

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