Apr 22, 2026
NRx said the FDA issued a positive review letter on its preservative-free ketamine ANDA, requesting only minor administrative changes. The company also received FDA guidance outlining a path to an NDA for NRX-100 using clinical trial data and real-world evidence.
Apr 03, 2026
A phase 3 clinical trial has launched for pridopidine as a potential ALS treatment, while AI research identified 18 FDA-approved drugs that may extend survival. Separate studies found a promising three-drug combination for sporadic ALS using new cell models.
Apr 01, 2026
A study of over 600,000 patients reveals GLP-1 drugs may reduce addiction across multiple substances, with 50% fewer substance-related deaths and significant reductions in overdoses and hospitalizations. The drugs work by dampening dopamine signaling in brain reward centers. Researchers are exploring broader applications for these medications beyond diabetes and obesity treatment.
Feb 25, 2026
Industry leaders highlight advances in AI-enabled trial monitoring, real-world data interoperability, and protocol-driven eSource systems, while emphasizing the need for community engagement in diversity efforts and addressing operational risks in rare disease trials.