To say that it has been an eventful few months for George Tidmarsh would be a bit of an understatement.
How George Tidmarsh crossed the FDA-industry Rubicon
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Chief, Division of Hematology, Professor of medicine, Sylvester Comprehensive Cancer Center, University of Miami; Author, “Drugs and the FDA: Safety, Efficacy, and the Public’s Trust”
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The FDA Oncologic Drugs Advisory Committee on April 30 considered two applications from AstraZeneca Pharmaceuticals LP.
FDA has accepted a New Drug Application for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act target action date is Feb. 27, 2027.
FDA has accepted for filing with Priority Review the supplemental Biologics License Application for Ziihera (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or gastroesophageal adenocarcinoma.
FDA announced that it has achieved its first-year goals in implementing its roadmap to reduce animal testing in preclinical studies.
