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FDA Approves FoundationOne CDx Companion Diagnostic for Selpercatinib in RET+ Solid Tumors

The FDA has approved FoundationOne CDx for use as a companion diagnostic for selpercatinib, which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion whose disease has progressed on or following prior systemic treatment, or who have no satisfactory alternative treatment options. ....

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U.S. Food and Drug Administration (FDA) Approves FoundationOne®CDx as a Companion Diagnostic for Lilly's Retevmo® (selpercatinib) for Certain Patients with Solid Tumors

U.S. Food and Drug Administration (FDA) Approves FoundationOne®CDx as a Companion Diagnostic for Lilly's Retevmo® (selpercatinib) for Certain Patients with Solid Tumors
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Dana-Farber spinout Precede exits stealth with blood test technology and $57M

BioPharma ....

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Akeega, an Oral Combo Therapy for BRCA-Mutated mCRPC, Gets FDA Approval

The FDA has approved Akeega (niraparib and abiraterone acetate) for BRCA-mutated metastatic castration-resistant prostate cancer. ....

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FDA Approves FoundationOne CDx as Companion Diagnostic for Niraparib/Abiraterone in mCRPC

The FDA companion diagnostic designation for FoundationOne CDx may improve access to niraparib/abiraterone acetate for eligible patients with metastatic castration-resistant prostate cancer (mCRPC) harboring a BRCA mutation. ....

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