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172,395 Results for "cdx laboratories cdx diagnostics".
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Press Releases
Tempus Announces the National Launch of FDA-Approved xT CDx Test
January 15, 2025
·
5 min read
Press Releases
U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for OJEMDA™ (tovorafenib) to Treat the Most Common Form of Childhood Brain Tumor in Pediatric Patients
January 17, 2025
·
5 min read
Press Releases
Telix Files TLX250-CDx (Zircaix®) BLA for Kidney Cancer Imaging
December 29, 2024
·
6 min read
Press Releases
Caris Life Sciences Receives FDA Approval for MI Cancer Seek™ as a Companion Diagnostic (CDx) Test
November 6, 2024
·
5 min read
FDA
U.S. Food and Drug Administration (FDA) Approves FoundationOne®Liquid CDx as a Companion Diagnostic for AKEEGA® (niraparib and abiraterone acetate) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for AKEEGA® (niraparib and abiraterone acetate) from Janssen Biotech, Inc.
July 1, 2024
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6 min read
Press Releases
NOBLE Registry Update: TLX599-CDx PSMA SPECT Imaging of Prostate Cancer Published in EJNMMI Reports
December 31, 2024
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9 min read
Biotech Bay
Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746).
May 21, 2024
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8 min read
Telix Completes TLX250-CDx (Zircaix™) BLA Submission for Kidney Cancer Imaging
Telix Pharmaceuticals Limited announces that it has completed the submission of a Biologics License Application to the United States Food and Drug Administration for its investigational radiodiagnostic PET1 agent, TLX250-CDx, for the characterisation of renal masses as clear cell renal cell carcinoma.
June 2, 2024
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7 min read
Policy
TLX101-CDx (Pixclara™) Granted FDA Fast Track Designation
Telix Pharmaceuticals Limited announces that the United States Food and Drug Administration has granted Fast Track designation for the Company’s investigational glioma imaging product, TLX101-CDx.
April 15, 2024
·
9 min read
Press Releases
U.S. Food and Drug Administration Approves FoundationOne®Liquid CDx as a Companion Diagnostic for TEPMETKO® (tepotinib) to Identify Patients with MET Exon 14 Skipping Alterations in Non-Small Cell Lung Cancer
November 18, 2024
·
4 min read
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