FDA
NYU Langone Health Gets FDA Clearance for Solid Tumor Gene Sequencing Test
The test uses next-generation sequencing to detect cancer-linked mutations in 607 genes to help guide patient treatment.
Merck's Keytruda Nets Two FDA Full Approvals in Triple-Negative Breast Cancer
The PD-1 inhibitor is now approved as neoadjuvant and adjuvant therapy for high-risk early-stage TNBC, as well as for later-stage, PD-L1-high TNBC patients with chemo.
Kronos Bio Gets FDA OK to Begin Phase I/II Trials of SYK Inhibitor in AML
Later this year, the company will begin studying lanraplenib in combination with Xospata in FLT3-mutated, relapsed, or refractory AML patients.
FDA Grants Full Approval to Merck, Eisai's Keytruda, Lenvima Combo in Endometrial Cancer
Based on results from the Phase III Keynote-775 trial, the agency converted its prior accelerated approval of the regimen to full approval.
Agilent Technologies Obtains CE Mark for Expanded Use of PD-L1 CDx in NSCLC
The firm said that the expanded use for its CDx will enable European pathologists to identify patients with NSCLC who may be eligible for treatment with cemiplimab.