RADNOR, Pa., Oct. 12, 2021 /PRNewswire/ — NRx Pharmaceuticals (Nasdaq: NRXP), today announced that a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) was submitted to the US Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. This module will now be used as part of […]
Aviptadil
NRx is pleased to announce that last week a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) was submitted to the US Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. This module will now be used as part of […]
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 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 […]
Every day at NRx we get a variety of questions about our science, business, and other aspects of our work. This CEO Update concerns aviptadil and questions about patents for this peptide. Q: What’s the difference between aviptadil and VIP?A: VIP stands for vasoactive intestinal peptide. It is made in specialized cells like insulin. Aviptadil is […]
We have received questions about the data submitted to the US Food and Drug Administration (FDA) in support of our application for Emergency Use Authorization for ZYESAMI™ to treat patients suffering from Critical COVID-19 with respiratory failure. Since there seems to be some confusion about what the preprint says, I’m going to restate the science. ALL PATIENTS […]
ZYESAMI™ (aviptadil) was awarded Fast Track Designation by the U.S. Food and Drug Administration for the Treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome Associated with COVID-19 Potential Applications for Dry Powder Formulation of ZYESAMI™ Extend to Many Pulmonary Conditions Beyond COVID-19 RADNOR, Pa., Aug. 4, 2021 /PRNewswire/ — NRx Pharmaceuticals (NRx) (Nasdaq: NRXP) announced today it has signed […]