The US Food and Drug Administration this week released its guidance document for developers of medical devices for COVID-19, including diagnostic tests, on how to transition from Emergency Use Authorization to full marketing and regulatory authorization.

Cue Health announced on Monday that it has received Emergency Use Authorization from the US Food and Drug Administration for its molecular monkeypox test.

The US Food and Drug Administration said on Friday evening that it has issued an Emergency Use Authorization for Lucira Health's Lucira COVID-19 & Flu test, the first over-the-counter, at-home diagnostic test that can differentiate and detect influenza A and B, as well as SARS-CoV-2.

The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for Mologic's over-the-counter SARS-CoV-2 antigen test.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Xpert Mpox test from molecular diagnostics company Cepheid.

The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for Anavasi Diagnostics' molecular point-of-care AscencioDx COVID-19 Test Kit.

LumiraDx said Monday that it had nabbed US Food and Drug Administration Emergency Use Authorization and UK Health Security Agency Coronavirus Test Approvals process validation for LumiraDx's laboratory-based multiplex test for COVID-19 and influenza A and B.

The US Food and Drug Administration said on Tuesday it has granted Emergency Use Authorization for DiaCarta's monkeypox PCR test.

The US Food and Drug Administration this week granted Emergency Use Authorization to Diazyme Laboratories for a SARS-CoV-2 total antibody test.

The European Commission has issued a Statement of Objections to Illumina and Grail on Monday, outlining the restorative measures it intends to adopt under the EU Merger Regulation.