FDA Approval Timeline of Active Immunotherapies | 合法醫療器材資訊網

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high ... On May 18, 2020, the Food and Drug Administration approved atezolizumab ... Read More

2020年5月29日 — The FDA recently approved the PD-L1 IHC 22C3 pharmDx – P150013/S014. The PD-L1 IHC 22C3 pharmDx – P150013/S014 is a lab test doctors use to ... Read More

2020年6月10日 — The PD-L1 IHC 28-8 pharmDx is a lab test doctors can use to identify if patients with non-small cell lung cancer (NSCLC) have the protein ... Read More

PD-L1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity. PD-L1 expression as detected by PD- ... Read More

Approval for the PD-L1 IHC 28-8 pharmDx for expanding the indications to squamous cell carcinoma of the head and neck, and urothelial cancer patients. Read More

Super Search Devices@FDA 6 ... The specimen should be considered to have PD-L1 expression if TPS >= 1% and high PD-L1 expression if TPS >= 50%. Read More

Timelines of FDA approvals in active immunotherapies, plus EMA, NDMA, and PDMA approvals of anti-PD-1/L1 antibody agents. Read More

The FDA has approved the PD-L1 (SP142) assay as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the ... Read More