NRx Pharmaceuticals (Nasdaq: NRXP) announced today that it has submitted an application for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) for the use of ZYESAMI® (aviptadil) in patients with Critical COVID-19 who are at immediate risk of death from Respiratory Failure despite treatment with approved therapy including Remdesivir and who are ineligible for enrollment into the ongoing ACTIV-3b NIH-sponsored trial.
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, […]
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 has Validated a Formulation, Manufacture, and Container Closure Method Suitable for High Volume Manufacture with Anticipated 1 year or greater stability