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The biotech has received written agreement from the agency through the START pilot program on key aspects of its trial design for evaluating NGN-401.
After an abnormal NIPT finding in a pregnant woman, a maternal-fetal medicine doctor orders a second NIPT, against recommendations.
Rutgers New Jersey Medical School has rolled out routine blood tests for the cardiovascular biomarker at another one of its affiliated hospitals.
With an FDA IND clearance, the firm will test IKS014 as an alternative for HER2-positive solid tumor patients in the US who have relapsed on other therapies.
The firms are planning two clinical trials of the anti-CTLA-4 agent muzastotug in colorectal cancer and in solid tumors.