Medical Device Network on MSN15d
FDA grants EUA to Aptitude’s Covid/flu multiplex test for OTC use
In partnership with Sekisui Diagnostics, the company and its distribution partners have made the test available across the US.
pharmaphorum2d
Pfizer, BioNTech submit to FDA for Covid vaccine in under 5s
The Pfizer/BioNTech bivalent COVID-19 vaccine (Original and Omicron BA.4/BA.5) has the FDA’s EUA for use in individuals 5 years and over as a single booster dose administered at least two months ...
Fox News6d
Trump FDA nominee turns vaccine question on Dem, recalling controversial Biden decision
after review of both Pfizer’s and Moderna’s EUA requests, the FDA concluded that the requests do not raise questions that would benefit from additional discussion by committee members." ...
Business Insider17d
Invivyd says FDA declines request to expand existing EUA of PEMGARDA
was declined by the U.S. Food and Drug Administration. Existing PEMGARDA EUA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients remains in effect. “This is a sad day ...
Nasdaq1mon
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 ...
Yahoo Finance23d
Hologic Announces FDA Clearance of Aptima SARS-CoV-2 Assay
February 18, 2025--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration ... Emergency Use Authorization (EUA) status in May 2020.