by TractManager | Jul 30, 2021 | Molecular Test Assessment
This report evaluates the analytical validity, clinical validity, and clinical utility of the Oncotype DX AR-V7 Nucleus Detect test.If you have a Hayes login, click here to view the full report on the Knowledge Center.
by TractManager | Jul 28, 2021 | News
The Food and Drug Administration (FDA) issued a safety alert for Pepaxto (melphalan flufenamide; Oncopeptides AB) based on results from the OCEAN trial, which demonstrated an increased risk of death.In February 2021, the FDA approved Pepaxto under Accelerated...
by TractManager | Jul 28, 2021 | Emerging Technology Report
Retifanlimab is an investigational intravenous humanized monoclonal antibody that inhibits the activity of programmed death-1 (PD-1). By blocking PD-1, retifanlimab acts as an immune checkpoint inhibitor, freeing T cells to kill cancer cells and boosting immune system...
by TractManager | Jul 21, 2021 | News
On July 16, the Food and Drug Administration (FDA) approved a new indication for Prograf (tacrolimus; Astellas Pharma US Inc.) based on observational study data providing real-world evidence (RWE) of effectiveness. It is the first drug approval based on RWE. The newly...
by TractManager | Jul 15, 2021 | News
The Food and Drug Administration (FDA) issued a safety communication regarding potential mechanical failures and concerns about biocompatibility associated with components of the following NuVasive Specialized Orthopedics MAGEC devices:MAGEC Spinal Bracing and...
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