EUA

An Independent Data Monitoring Committee (IDMC) has recommended that the Phase 3 COMET-ICE trial, evaluating VIR-7831 (GSK4182136) as monotherapy for COVID-19, stop enrollment due to evidence of profound efficacy. The antibody treatment is being developed under a collaboration between...

The FDA has granted Emergency Use (EUA) approval for Fluidigm Corporation's (NASDAQ: FLDM) AZOVA COVID-19 test collection kit for use with the company's Advanta Dx SARS-CoV-2 RT-PCR Assay on its Biomark HD platform. The kit is authorized for at-home self-collection by...

The FDA has granted Emergency Use Authorization (EUA) to Becton Dickinson and Co's (NYSE: BDX) new molecular test for both SARS-CoV-2 and Influenza A+B. The new test has also received a CE mark in Europe. The new EUA includes updated information in the test's...