US Food and Drug Administration

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 […]

NRx Pharmaceuticals Receives US Food and Drug Administration Review of ZYESAMI® (aviptadil) Manufacturing Information

US Food and Drug Administration Review Allows for High Volume Production of ZYESAMI® (aviptadil) Shelf Life of ZYESAMI Now Extended from 62 Days to 150 Days RADNOR, Pa., Nov. 11, 2021 (GLOBE NEWSWIRE) — NRx Pharmaceuticals (NASDAQ: NRXP), today announced receipt of the US Food and Drug Administration’s (FDA) response to NRx’s October 8 submission of […]

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, […]