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All Oncology News

The FDA has approved the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst), which now has has approved indications for HER2-positive patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma.

The FDA announced that it has approved the FoundationOne CDx assay. The Centers for Medicare & Medicaid Services issued a simultaneous announcement saying the next-generation sequencing-based in vitro diagnostic test will be covered by insurance.