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

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

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 ...

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 ...

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

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 ...

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 ...

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.

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