The FDA’s approval on Thursday for BioMarin’s Roctavian gene therapy for severe hemophilia A came with a second approval attached: for a companion diagnostic that can identify which patients may be ...
The FDA approved the Oncomine Dx Target Test for identifying HER2-mutant NSCLC patients eligible for Hernexeos, an oral tyrosine kinase inhibitor. Hernexeos offers a new treatment option for ...
(RTTNews) - Guardant Health, Inc. (GH) said Thursday that the U.S. Food and Drug Administration has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic for patients with BRAF ...
The universe of precision medicine in oncology is large and expanding. With new targeted drugs and companion testing, people with mutation-driven cancers now have care opportunities that have never ...
The U.S. Department of Health and Human Services Office of Inspector General (OIG) once again addressed an industry-sponsored genetic testing program, posting a favorable decision on July 2, 2025 in ...
Seattle's NanoString Technologies ($NSTG) stands to make up to $45 million if it can come up with a successful companion diagnostic test to screen for a subset of ...
The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process by which FDA will offer ...
Source BioScience plc (LSE: SBS), the provider of expert, quality services to the life science research, pharma biotech and healthcare sectors, is pleased to announce that the Company will provide a ...
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