CROSSJECT and its EUROFINS CDMO partner successfully completed the aseptic filling of all ZEPIZURE® registration batches and anticipate the delivery of the last manufacturing data needed for U.S. Food ...

Milwaukee-based architecture firm EUA announced that Kristin Dufek will become the firm’s new chief executive officer, effective Aug. 1. The change is part of a planned succession as current CEO Rich ...

After a daylong meeting, an FDA advisory panel agreed that the second vaccine in the United States to prevent coronavirus disease 2019 (COVID-19) should be put forward for use. An FDA advisory panel ...

When Veru swiftly wrapped up a phase 3 trial of its COVID treatment last April, expectations bubbled that the company may be able to pry one more emergency use authorization from the FDA. Those dreams ...

Early this week cardiac-focused digital health company Eko scored a temporary Emergency Use Authorization (EUA) for its ECG low ejection fraction tool, which can be used to help clinicians spot ...

Propelled by the COVID-19 pandemic, a new, shortened route to market uptake for some investigational drugs and devices has leaped into public awareness. Companies considering this avenue must ...

F10 Antiseptic Wound Spray with Insecticide received the EUA based on scientific evidence available. The FDA announced earlier this week it issued an Emergency Use Authorization (EUA) for benzalkonium ...

The FDA late Friday issued an emergency use authorization (EUA) for a vaccine to prevent coronavirus disease 2019 (COVID-19) from Pfizer and BioNTech, a day after an advisory panel recommended its use ...