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Foundation Medicine’s FoundationOne CDx Receives the US FDA’s Approval as a CDx for Vitrakvi (larotrectinib)

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Shots: The US FDA approved FoundationOneCDx to be used as a CDx for Vitrakvi (larotrectinib) to identify patients with NTRK fusions across all solid tumors. The genomic test is currently approved as a CDx for 20+ therapies The FoundationOne CDx is the tissue-based CGP test… Read More »Foundation Medicine’s FoundationOne CDx Receives the US FDA’s Approval as a CDx for Vitrakvi (larotrectinib)

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

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Shots: The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21 The acceptance is based on the efficacy and safety profile of Xolair in… Read More »Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications