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FDA Approvals, News & Updates



Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold. Read More ›







On September 27, 2018, the FDA approved the targeted therapy dacomitinib (Vizimpro; Pfizer), an oral kinase inhibitor, for the first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) associated with EGFR exon 19 deletion or exon 21 L858R substitution mutations, as identified by an FDA-approved test. Read More ›

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