BioSpace13h
FDA Shoots Down Invivyd’s Bid to Expand EUA for COVID-19 Antibody
Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent ...
FDA Rejects Invivyd's Request To Expand Emergency Authorization For Preventive COVID-19 Antibody For Immunocompromised Patients
Invivyd's bid to expand Pemgarda's EUA for COVID-19 treatment was denied by the FDA. The company will share new data on ...
Invivyd says FDA declines request to expand existing EUA of PEMGARDA
Invivyd (IVVD) announced that Invivyd’s request to expand the existing emergency use authorization for pre-exposure prophylaxis of COVID-19 EUA ...
Invivyd news ‘disappointing’ but not in model, says H.C. Wainwright
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 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 ...
Invivyd, Inc.: FDA Declined Invivyd's Request to Expand Existing Emergency Use Authorization of PEMGARDA (pemivibart)
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 ...
Invivyd Shares Down as Regulators Decline Expanded Use for Covid-19 Treatment
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 ...
pharmaphorum5d
AstraZeneca files rival to Pemgarda for COVID PrEP
There is currently one antibody available for PrEP in COVID-19 – Invivyd’s Pemgarda (pemivibart) – which was granted Emergency Use Authorization (EUA) in the US in March for adults and ...
Seeking Alpha20d
I See The Bull Case For Invivyd, But I'm Not Married To It
On top of that, PEMGARDA’s Emergency Use Authorization (EUA) status makes things a bit precarious. Its sales depend entirely on viral variants staying susceptible and regulators continuing to ...
Nasdaq28d
Invivyd Submits Updated Immunobridging Data To FDA For PEMGARDA EUA Amendment
on Monday announced the submission of an updated immunobridging analysis to the U.S. Food and Drug Administration or FDA in support of its Emergency Use Authorization or EUA amendment request for ...
Healthline12d
Pemgarda Side Effects and Tips for Managing Them
Pemgarda (pemivibart) can cause side effects that range from mild to serious. More common side effects include fatigue and infusion-related reactions. If side effects become difficult to tolerate ...
Stockhouse1mon
Invivyd Announces Continued Neutralizing Activity of PEMGARDA(TM) (pemivibart) Against Dominant SARS-CoV-2 Variant XEC
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during ...