PMA
FDA Accepts Invitae Premarket Approval Submission for Stratafide Companion Diagnostic
The regulatory submission triggers a milestone payment, and Invitae will issue 5 million shares of its common stock to former ArcherDx securityholders.
Allarity Pushes Back NDA Filing for Kidney Cancer Drug to 2021
Although pandemic-related manufacturing delays impacted the NDA filing, the company remains on track to file its PMA for the companion diagnostic by year end.
Invivoscribe Receives Supplemental Approval for AML Kit
The firm has received a supplemental approval that provides its customers with an option to purchase its IVD-labeled FLT3 mutation assay for in-house testing.
GSK Gets Broad Zejula Indication in Ovarian Cancer; FDA Deems Myriad Genetics' Test Complementary
The drugmaker will promote Zejula without a biomarker as a first-line maintenance option, and Myriad will highlight that patients with HRD are most likely to benefit.
Caris Life Sciences Seeks FDA Approval for Exome, Transcriptome CDx Assays
The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity.