Invivyd's bid to expand Pemgarda's EUA for COVID-19 treatment was denied by the FDA. The company will share new data on ...
An approval for the first drug for a rare lipid storage disease, some FDA workers rehired, and other biotech news of the day ...
The Trump administration has started quietly re-hiring some of the FDA employees that it fired last week in a process that insiders called abrupt and haphazard, STAT’s Lizzy Lawrence reports. The ...
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 ...
Invivyd (IVVD) announced that Invivyd’s request to expand the existing emergency use authorization for pre-exposure prophylaxis of COVID-19 EUA ...
The commercial-stage biopharmaceutical company said its request to expand the existing emergency use authorization of the drug, also called pemivibart, to treat mild-to-moderate Covid-19 in more ...
I had a box of iHealth test kits that said they were to be used by July 2022, and their dates had not been extended any ...
Moderna said on Friday that the U.S. FDA paused a late-stage trial of its experimental norovirus vaccine after a case of a ...
After it was reported the Trump administration would be ending the free COVID test program, the Department of Health ...
Ky., on Wednesday called on the Food and Drug Administration to reverse its approval of COVID-19 vaccines the agency has ...
The decision to withdraw is based on discussions Co-Diagnostics had with the FDA about the ability to detect a potential deterioration of one component of the test, related to shelf-life stability, it ...
As COVID-19 surged across the US starting in 2020, so too did the use of repurposed medications such as hydroxychloroquine and ivermectin to treat COVID-19 infections. Use of these medications ...