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EUA

CEO Update: ZYESAMI® (aviptadil) Next Steps

I recently received the letter below from a shareholder. The correspondence from them (taken exactly from their email) and my response regarding our next steps for ZYESAMI ® (aviptadil) can be found below. Email from R.B., a shareholder of NRx Pharmaceuticals Dear Dr. Javitt I have been heartbroken since the denied emergency approval for Zyesami/Aviptadil. […]

US Food and Drug Administration Declines Emergency Use Authorization for ZYESAMI® (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure

NRx Pharmaceuticals Has Requested a Type A Meeting with US Food and Drug Administration (FDA) to Include Treating Physicians and Patients FDA Commits to Working with NRx to Develop ZYESAMI® ZYESAMI Clinical Trials Funded by the US National Institutes of Health and BARDA Continue and Advance Towards Enrollment in Brazil and Europe RADNOR, Pa., Nov. 4, […]

CEO Update: Nation of Georgia Emergency Use Authorization

We have received several questions about the status of the Emergency Use Authorization granted to aviptadil in the Nation of Georgia.  Attached please find a copy of the official notification from the Regulation Agency for Medical and Pharmaceutical Activities of the Nation of Georgia, that states as follows: 06 August 2021 Georgian Respiratory Association to […]

CEO Update: Ongoing Communications with the US Food and Drug Administration

NRx Pharmaceuticals continues to receive many requests for updates on the status of the US Food and Drug Administration’s (FDA) review of NRx’s application for Emergency Use Authorization (EUA) of ZYESAMI™ (aviptadil), to treat patients suffering from Critical COVID-19 with respiratory failure. On September 3, 2021, NRx received a request for additional clinical information from […]

NRx Pharmaceuticals Announces 2nd Quarter 2021 Financial Update

Emergency Use Authorization (EUA) Request for ZYESAMI™ (aviptadil) Pending with United States Food and Drug Administration to Treat Patients Suffering from Critical COVID-19 with Respiratory Failure Emergency Use Authorization Granted to ZYESAMI in Nation of Georgia to Treat Critical COVID-19 Patients in July; First Orders for ZYESAMI in Georgia Under Discussion NRx Pharmaceuticals Initiating Phase […]

NRx Pharmaceuticals Presents Evidence ZYESAMI™ (aviptadil) Helps Prevent “Cytokine Storm” in Patients with COVID-19

Sudden Rise in Inflammatory Cytokines (IL-6) Associated with Death in COVID-19 and Other Forms of Acute Respiratory Distress Syndrome Data from Randomized Phase 2b/3 Trial Shows Patients Treated with ZYESAMI™ are Significantly Less Likely to Experience IL-6 Cytokine Rise, and Have Improved Survival and Recovery from Respiratory Failure, Compared to Patients Receiving Placebo Data Have […]