FDA

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 […]

CEO Update: ZYESAMI® (aviptadil) Next Steps

I recently received the letter below from a shareholder. The correspondence from them (taken exactly from their email) and my response regarding our next steps for ZYESAMI ® (aviptadil) can be found below. Email from R.B., a shareholder of NRx Pharmaceuticals Dear Dr. Javitt I have been heartbroken since the denied emergency approval for Zyesami/Aviptadil. […]

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, […]

CEO Update: Ongoing Communications with the US Food and Drug Administration

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 Pharmaceuticals Presents Evidence ZYESAMI™ (aviptadil) Helps Prevent “Cytokine Storm” in Patients with COVID-19

Sudden Rise in Inflammatory Cytokines (IL-6) Associated with Death in COVID-19 and Other Forms of Acute Respiratory Distress Syndrome Data from Randomized Phase 2b/3 Trial Shows Patients Treated with ZYESAMI™ are Significantly Less Likely to Experience IL-6 Cytokine Rise, and Have Improved Survival and Recovery from Respiratory Failure, Compared to Patients Receiving Placebo Data Have […]

Humanigen, NeuroRx Plan FDA Emergency Use Filings for COVID-19 Candidates

Mar 30, 2021 Genetic Engineering and Biotechnology News Two COVID-19 drug developers said they will seek emergency use authorizations (EUAs) from the FDA for their therapeutics following positive late-stage clinical results. Humanigen disclosed topline Phase III results showing that hospitalized patients who received lenzilumab and other treatments—including steroids and/or Gilead Sciences’ marketed drug Veklury® (remdesivir)—had a 54% greater […]

Which COVID-19 treatments are showing promise? A list of potential drugs

By Lia Eustachewich, NY Post The race is on to find a treatment that works to quash the coronavirus — as the deadly disease continues to spread across the globe. Here’s a list of the most promising treatments and potential vaccines for SARS-CoV-2, the virus that causes COVID-19. Remdesivir The experimental antiviral drug, made by Gilead Sciences, was […]

RLF-100 (aviptadil) clinical trial showed rapid recovery from respiratory failure and inhibition of coronavirus replication in human lung cells

CISION PR Newswire – Rapid recovery of patients on ventilators and ECMO (extracorporeal membrane oxygenation) was seen in patients with severe medical comorbidities after three days of treatment with RLF-100 under FDA Emergency Use IND authorization at multiple clinical sites – Aviptadil is being developed as the first COVID therapeutic to block replication of the […]