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

After the Public Health Emergency: FDA plans to revise COVID-19 EUA policies

On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to ...
Healthcare Dive

Watchdog faults FDA for rushing COVID tests to market by easing emergency use rules

The Food and Drug Administration repeatedly changed its emergency use authorization policies to address the need for COVID-19 testing, allowing problematic tests to be distributed, according to a ...
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 ...
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 ...