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BioWorld - Saturday, December 27, 2025
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FDA clears first whole exome sequencing platform for overall tumor mutation burden

Nov. 13, 2019
By Meg Bryant
Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
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Regulatory front for Nov. 13, 2019

Nov. 13, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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FDA clears first whole exome sequencing platform for overall tumor mutation burden

Nov. 13, 2019
By Meg Bryant
Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
Read More

European Commission grants conditional marketing authorization to Ebola Zaire vaccine Ervebo

Nov. 12, 2019

Regulatory front for Nov. 12, 2019

Nov. 12, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory front for Nov. 12, 2019

Nov. 12, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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FDA approves Reblozyl for anemia in beta thalassemia requiring regular RBC transfusions

Nov. 11, 2019

Regulatory front for Nov. 11, 2019

Nov. 11, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Latest telehealth bill would dismantle some geographic restrictions

Nov. 11, 2019
By Mark McCarty
Advocates of telehealth are backing the bipartisan, bicameral Connect for Health Act of 2019, which would eliminate geographic and origination site restrictions on Medicare coverage and save billions of taxpayer dollars.
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Acceleron's Celgene-partnered luspatercept wins FDA nod in beta-thalassemia

Nov. 10, 2019
By Jennifer Boggs
Nearly a month ahead of the PDUFA date, red blood cell maturation drug luspatercept cleared the FDA for treating anemia in adults with beta-thalassemia who require regular red blood cell (RBC) transfusions. Branded Reblozyl, the drug, developed in a collaboration between Celgene Corp. and Acceleron Pharma Inc., is expected to be available in one week following approval.
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