Healthcare Dive

FDA issues first EUA for monkeypox test

The Food and Drug Administration on Wednesday shared guidance on how developers can seek emergency use authorization for monkeypox tests. The agency said it intends to prioritize review of EUA ...
RAPS

FDA updates EUA guidance, addressing vaccines against COVID variants

The US Food and Drug Administration (FDA) has revised its guidance for developers of vaccines against COVID-19 as regulators and health authorities assess the need to adjust vaccines so they remain ...
RAPS

FDA issues COVID-19 vaccine EUA guidance after clash with White House

Amid reports that the White House had blocked stricter guidance from the US Food and Drug Administration (FDA) on emergency use authorizations (EUAs) for COVID-19 vaccines, the agency on Tuesday ...
JD Supra

FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence

The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the ...
Nasdaq

Invivyd Submits Updated Immunobridging Data To FDA For PEMGARDA EUA Amendment

(RTTNews) - Invivyd, Inc. (IVVD), a biopharmaceutical company, on Monday announced the submission of an updated immunobridging analysis to the U.S. Food and Drug Administration or FDA in support of ...
Nasdaq

Invivyd Announces U.S. FDA Has Updated the PEMGARDA™ EUA Fact Sheet with Accurate SARS-CoV-2 Variant Susceptibility and PEMGARDA Activity Data

KP.3.1.1 and LB.1 in vitro neutralization potency values now reflected in the PEMGARDA Fact Sheet for Healthcare Providers are in-line with prior variants, including variants represented in the CANOPY ...