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FDA

Jonathan Javitt, NRx Pharmaceuticals, gives keynote address at Sachs Neuroscience Innovation Forum
Jan. 10, 2024
Jonathan Javitt, MD, MPH, Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals, gives the keynote address “Ketamine for Suicidal Depression: The Benefits are Clear, But So are the Risks,” at the Sachs Neuroscience Innovation Forum in San Francisco, CA on January 7, 2024

Jonathan Javitt, MD, MPH, Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals, gives the keynote address “Ketamine for Suicidal Depression: The Benefits are Clear, But So are the Risks,” at the Sachs Neuroscience Innovation Forum in San Francisco, CA on January 7, 2024.

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NRx Press Release
Jul. 1, 2022
FDA Declines Emergency Use Authorization for ZYESAMI® (aviptadil) for subgroup of Patients with Critical COVID-19 at immediate risk of death from respiratory failure despite treatment with approved therapy, including remdesivir

NRx Pharmaceuticals, Inc. today announced that the US Food and Drug Administration (FDA) has declined to issue an Emergency Use Authorization (EUA) for ZYESAMI® (aviptadil) for a sub-group of patients that in addition to ZYESAMI®, also received Remdesivir and continued to progress.

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CEO Update
Nov. 22, 2021
CEO Update: Denial of Breakthrough Therapy Designation

The US Food and Drug Administration (FDA) denied NRx Pharmaceuticals’ (NRx) request for Breakthrough Therapy Designation (BTD) for ZYESAMI® (aviptadil). BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with […]

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