regulatory approval
Review of Approval Process
Stat News reports the Department for Health and Human Services' Office of the Inspector General is to investigate FDA's approval of Biogen's Alzheimer's disease drug.
Pillar Biosciences Receives FDA Approval for OncoReveal Dx Lung and Colon Cancer Assay
The IVD, intended for use on the Illumina MiSeq Dx, detects somatic mutations in tumor tissue samples to guide the use of anti-EGFR therapy where indicated.
September Plans
The New York Times reports that the US Food and Drug Administration is aiming for early September for full approval of the Pfizer-BioNTech SARS-CoV-2 vaccine.
Push Toward Approval
The Wall Street Journal reports the US Food and Drug Administration is under pressure to grant full approval to SARS-CoV-2 vaccines.
Hologic Receives CE Mark for Molecular Test to Quantify Cytomegalovirus
The assay, which quantifies the human cytomegalovirus viral load in transplant patients, represents a new market opportunity for Hologic's MDx business.