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The company will advance CAR T-cell therapies for solid tumors based on Unum's BOXR cell-based therapy platform and open an R&D facility in Cambridge, Mass.
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.
Kinnate aims to advance its lead candidates into clinical trials next year and collaborate with investigators at precision cancer centers on future research projects.
The agency granted the NDA priority review, putting the application on a six-month review clock, instead of the 10-month standard review time frame.
Maple Grove, Minnesota-based Stemonix will merge in an all-equity transaction with a newly formed subsidiary of Cancer Genetics, which expects to remain listed on the Nasdaq.
Awaiting data from the Phase II SOLAR trial, miRagen is looking to potentially advance cobomarsen into registration-enabling studies for miR-155 elevated CTCL and ATLL.
Senaparib is currently being studied in a Phase II trial as a monotherapy for BRCA-mutated ovarian cancer patients who have received at least two prior lines of therapy.
AmoyDx aims to develop a companion diagnostic for Merck KGaA's non-small cell lung cancer treatment Tepmetko, which was recently approved in Japan.
The firm said its genetic tests for breast, prostate, and colorectal cancers and melanoma assess a patient's personal cancer risks and guide personalized prevention.
The collaboration will focus on the discovery, development, and commercialization of targeted immune evasion therapies for patients with cancer.
Under the terms of the agreement Thermo Fisher will retain the rights to commercialize the companion test globally and seek regulatory approval.
The Chicago-based precision medicine software startup raised the funds through a Series A round led by digital health-focused venture capital firm HealthX Ventures.
The drugmaker said it is working with centers of excellence in Canada to set up companion diagnostic testing to identify patients with PIK3CA mutations.
The University of California, San Diego spinout is developing a technology that uses microbial DNA signatures for the early detection of cancer.
The agreement will facilitate key proof-of-concept studies for Hemogenyx's HEMO-CAR-T product in AML, where there is an unmet need for new safe and effective treatments.
The drug developer will submit a new drug application with the FDA based on the Phase III study results presented at a medical conference last week.
The drug is now approved in Hong Kong, China, and Taiwan as an extended adjuvant treatment for adult patients with early-stage, HER2-positive breast cancer.
Researchers will use the funds to explore if the device can deplete circulating exosomes and make head and neck cancer patients more responsive to treatments.
The sequencing-based test for minimal residual disease can be use with blood and bone marrow samples in patients with chronic lymphocytic leukemia.
Entrectinib is authorized for advanced NTRK fusion-positive solid tumors with no alternative treatment, and ROS1-positive NSCLC patients.