Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent ...

FDA denies Invivyd's EUA expansion for Pemgarda in Covid treatment while BioCryst reports positive Orladeyo data. AN2 changes endpoint, OS Therapies seeks partners & Eyenovia restructures.

H.C. Wainwright maintains a Buy rating on Invivyd (IVVD) with a $10 price target after the FDA rejected its submission to expand Pemgarda’s ...

After a weak start to 2025, Wall Street regained momentum, driven by solid corporate earnings and advancements in AI. The S&P 500 touched record highs on several occasions, having risen 2.2%, while ...

Invivyd's bid to expand Pemgarda's EUA for COVID-19 treatment was denied by the FDA. The company will share new data on ...

FDA's reasoning appears to center on a belief that COVID-19 treatment immunobridging analyses for a monoclonal antibody (mAb) must meet a standard of superior antiviral activity rather than equivalent ...

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 ...

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 ...

Invivyd (IVVD) announced that Invivyd’s request to expand the existing emergency use authorization for pre-exposure prophylaxis of COVID-19 EUA ...

We recently compiled a list of the 10 Micro and Small-Cap Firms Drive Year-to-Date Gains. In this article, we are going to ...