Search This Blog

Tuesday, October 31, 2023

X4 FDA Acceptance with Priority Review of U.S. NDA

 FDA sets a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024

If the NDA is approved, company eligible to receive a Priority Review Voucher (PRV) resulting from mavorixafor’s rare pediatric designation in WHIM syndrome

NDA supported by positive results from global, pivotal 4WHIM Phase 3 clinical trial

https://www.biospace.com/article/releases/x4-pharmaceuticals-announces-fda-acceptance-with-priority-review-of-u-s-nda-for-mavorixafor-in-whim-syndrome/

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.