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FDA Grants Fast Track Designation to QRX003, Supports NRX-100 NDA

Jul 29, 2026

The FDA granted Fast Track Designation to Quoin's QRX003 for Netherton Syndrome and supported NRx's NRX-100 NDA path under Fast Track for treatment-resistant depression, addressing serious unmet needs.

NRx Pharmaceuticals Receives FDA Guidance on New Drug Application Path for NRX-100

Feb 17, 2026

NRx Pharmaceuticals completed a Type C meeting with FDA leadership and received oral guidance supporting a New Drug Application for NRX-100 (preservative-free ketamine) based on existing trial data and Real World Evidence from over 65,000 patients.