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, […]
Covid-19
After Review of More than 300 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board; Study Cleared to Continue Enrollment to Target 640 Patients ACTIV-3b Critical Care Study is Evaluating ZYESAMI® (aviptadil) and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo ACTIV-3b […]
To Our Shareholders, We have received many inquiries from shareholders following the recent encouraging news regarding Merck’s Molnupiravir results in early COVID-19. We have also received various questions about the status of our application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for ZYESAMI. Needless to say, we are […]
ZYESAMI™ (aviptadil) Has Previously Demonstrated a Statistically Significant Increase in Survival of Highly Comorbid COVID-19 Patients in Two 60-day Trials In a Study of Highly Comorbid Patients, ZYESAMI Provided a Threefold, Statistically Significant Increase in Likelihood of Survival at One Year RADNOR, Pa., Sept. 27, 2021 /PRNewswire/ — NRx Pharmaceuticals (Nasdaq: NRXP), a clinical stage, biopharmaceutical […]
You may have noted a previous update regarding communication with the FDA. Earlier this month, NRx received a request for additional clinical information from the FDA. NRx has responded to the information request issued by the FDA with regard to additional clinical information on study patients. Ongoing conversations between the FDA and sponsor of any application […]
I received a very interesting question the other day regarding the history of aviptadil and any regulatory milestones associated with it as a medicine. Below, I outline a brief history of aviptadil and why we believe it may offer patients suffering respiratory distress the opportunity to regain health and get back home to their families. […]
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 Provided Updated Data to US Food and Drug Administration (FDA) in Support of Emergency Use Authorization Request for ZYESAMI™ (aviptadil) NRx to Submit Breakthrough Therapy Designation to FDA for ZYESAMI™ for the Treatment of Respiratory Failure in Patients with Critical COVID-19 RADNOR, Pa., Aug. 30, 2021 /PRNewswire/ — NRx Pharmaceuticals (NRx) (Nasdaq: NRXP) announced an additional finding […]
Agreement Represents Path to Market for ZYESAMI™, as Time to Treatment is Crucial for Patients Cardinal Health Third Party Logistics Services to Provide Logistical and Distribution Support for ZYESAMI™ (aviptadil) Upon Potential FDA Approval Cardinal Health Specialty Pharmaceutical Distribution to Serve as the Exclusive Distributor to Ensure Access to ZYESAMI™ (aviptadil) Upon Potential FDA Approval […]