Do Hydroxychloroquine and Ivermectin Work?
A September 2024 article in the journal Biomedicines reviewing the findings of clinical trials for ivermectin and chloroquine ...
Trump FDA nominee turns vaccine question on Dem, recalling controversial Biden decision
Dr. Marty Makary, President Donald Trump's choice to lead the Food and Drug Administration, pointed out the Biden ...
Invivyd Announces Continued Neutralizing Activity of PEMGARDA (pemivibart) Against Currently Dominant SARS-CoV-2 Variant LP.8.1
New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA (pemivibart) against LP.8.1 Centers for Disease Control reports LP.8.1, XEC and KP.3.1.1 together constitu ...
Le Lézard16d
Visby Medicaltm Receives FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test
Visby Medicaltm announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for its point-of-care respiratory health test.
Medical Device Network on MSN16d
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.
CNN17d
FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect
The US Food and Drug Administration’s new standards for foods before they can be labeled as “healthy” on their packaging will go into effect about two months later than planned, according to ...
Medical Device Network17d
FDA grants EUA to Aptitude’s Covid/flu multiplex test for OTC use
Credit: PeopleImages.com – Yuri A / Shutterstock. The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Aptitude Medical Systems’ Metrix Covid/Flu multiplex test ...
Aptitude Receives FDA Authorization for Metrix® COVID/Flu Multiplex Molecular Test for Point-of-Care and Over-the-Counter Use
Aptitude Medical Systems, Inc. (Aptitude) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its next-gen molecular Metrix® ...
Invivyd shares drop as FDA declines company's COVID-19 treatment EUA expansion
Monday said that its request to expand the existing emergency use authorization of PEMGARDA (pemivibart) to include treatment of mild-to-moderate COVID-19 for immunocompromised persons who have no ...
Business Insider18d
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 ...
BioSpace18d
FDA Shoots Down Invivyd’s Bid to Expand EUA for COVID-19 Antibody
The emergency use authorization (EUA) for Pemgarda as a pre-exposure prophylactic, which the company received from the FDA last March, is still in effect. The Waltham, MA–based company made the ...