• NRX Pharmaceuticals received FDA notice reclassifying its ketamine ANDA amendment from major to minor, easing the review burden.
• FDA reset the GDUFA target action date to Nov. 10, 2026.
• Shorter review timeline could accelerate potential clearance of preservative-free ketamine, a product tied to U.S. drug-shortage demand.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NRX Pharmaceuticals Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001437749-26-030492), on September 16, 2026, and is solely responsible for the information contained therein.