First Ever Breakthrough Designation for a Drug Being Developed for PWS
Designation is Based on Data from the Phase 3 Program for DCCR
Planned Submission of a New Drug Application (NDA) for DCCR Remains on Track for Mid-2024
https://www.globenewswire.com/news-release/2024/04/29/2871167/0/en/Soleno-Therapeutics-Receives-Breakthrough-Therapy-Designation-from-U-S-FDA-for-DCCR-Diazoxide-Choline-Extended-Release-Tablets-in-Prader-Willi-Syndrome-PWS.html
Note: Only a member of this blog may post a comment.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.