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.
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.
NRx Pharmaceuticals, Inc. today announced results of a review conducted by the Data Safety and Monitoring Board (DSMB) on May 25, 2022. The DSMB reviewed data of approximately 460 patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b (TESICO) trial, most of which had reached the 90-day endpoint.
NRx Pharmaceuticals, Inc. today announced that it has filed a new Breakthrough Therapy designation request with the U.S. Food and Drug Administration (FDA) focused on a subgroup of patients with Critical COVID-19 that in addition to aviptadil or placebo were also treated with remdesivir. The request includes safety data on approximately 750 patients treated with intravenous ZYESAMI® for Critical COVID-19.
Quantum Leap Healthcare Collaborative (QLHC) announced in collaboration with NRx Pharmaceuticals, Inc. (NRx), that the nebulized form of ZYESAMI® (Aviptadil), in the I-SPY COVID Trial of Critical COVID-19 patients has been stopped.
NRx Pharmaceuticals has received a first safety report from a Southwestern hospital where physicians have administered ZYESAMI® (Aviptadil) to patients with COVID-19 respiratory failure.
NRx Pharmaceuticals announced the conclusion of high-level meetings in Hungary that are expected to lead to utilization of ZYESAMI® (aviptadil) in that country and the pivotal clinical trial of the BriLife COVID-19 vaccine (BriLife).
Analysis was conducted in the subgroup of ZYESAMI- and placebo-treated patients who were previously treated with remdesivir in the COVID-AIV trial representing approximately 70 percent of the study population Analysis was conducted in response to US Food and Drug Administration (FDA) request for additional clinical data on effect of ZYESAMI compared to currently-approved therapy including […]
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 […]