AnHeart Therapeutics and Foundation Medicine Inc. have entered a strategic collaboration for the development and regulatory approval of Foundation Medicine’s tissue- and liquid-based comprehensive genomic profiling tests, FoundationOne CDx and FoundationOne Liquid CDx, as companion diagnostics for AnHeart’s investigational next-generation ROS1 inhibitor, taletrectinib, in the United States.
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.
