The US Food and Drug Administration on Thursday granted separate Emergency Use Authorizations (EUAs) for PCR-based SARS-CoV-2 tests developed by South Korean diagnostic test makers BioCore, SolGent, and Seasun Biomaterials.

The US Food and Drug Administration on Wednesday announced the approval of AstraZeneca and Merck's olaparib (Lynparza) for metastatic castration-resistant prostate cancer patients with homologous recombination repair deficiency.

P23 Labs has received Emergency Use Authorization for its coronavirus PCR test from the US Food and Drug Administration.

The US Food and Drug Administration on Thursday granted separate Emergency Use Authorizations (EUAs) for PCR-based SARS-CoV-2 tests developed by South Korean diagnostic test makers BioCore, SolGent, and Seasun Biomaterials.

Grifols Diagnostic Solutions announced Thursday its Procelix Panther System featuring Automation Ready Technology (ART) received approval from the US Food and Drug Administration.

Moderator: Irene Aihie April 22, 2020 12:15 pm ET Coordinator: Welcome and thank you for standing by. At this time all parties are in a listen-only mode until the question and answer segment of todays conference at which time you may press

South Korean molecular diagnostics firm Seegene announced after the close of the market on Tuesday that the US Food and Drug Administration has granted Emergency Use Authorization for the firms Allplex 2019-nCoV Assay, a real-time RT-PCR te

The US Food and Drug Administration on Friday granted Emergency Use Authorization to the Rutgers Clinical Genomics Laboratory for a SARS-CoV-2 test originally developed by Thermo Fisher Scientific that is modified for use on additional spec

The US Food and Drug Administration on Friday granted Emergency Use Authorization to the Rutgers Clinical Genomics Laboratory for a SARS-CoV-2 test originally developed by Thermo Fisher Scientific that is modified for use on additional spec

The US Food and Drug Administration on Monday granted Emergency Use Authorization to two lab-developed real-time RT-PCR tests for SARS-CoV-2, the virus that causes coronavirus disease COVID-19. The authorized tests are performed at Knoxvill