Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
In Brief This Week: Day One, Sophia Genetics, Genetron Health, Global Cancer Technology
News items for the week of July 26, 2021.
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.
Healthcare Providers Adjust to Anti-Information Blocking Regulation Impact on Patient Interactions
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The regulations have received a tepid reception from some doctors worried about patients finding out sensitive information online without support.