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.
Jul. 1, 2022FDA 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
Jun. 10, 2022NRx Pharmaceuticals Provides Update on Breakthrough Therapy Designation (BTD) Request for ZYESAMI® (aviptadil)
NRx Pharmaceuticals, Inc. today announced that the FDA denied the Breakthrough Therapy designation (BTD) request for ZYESAMI® (aviptadil) and emphasizes focus on its NRX-101 BTD compound for Bipolar Depression associated with Suicidality.