BioLineRx Announces U.S. FDA Acceptance of New Drug Application for Aphexda (motixafortide) in Stem Cell Mobilization

PDUFA target action date set for September 9, 2023 NDA submission based on GENESIS Phase 3 trial data that met all primary and secondary endpoints with a high level of statistical significance Company advancing preparations for robust commercial...
Source: Drugs.com - New Drug Applications - Category: Drugs & Pharmacology Source Type: news