Theratechnologies: FDA continues to review file past PDUFA date

 Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin. The FDA has notified the Company that it is continuing its review of the application beyond the Prescription Drug User Fee Act (PDUFA) goal date of January 22, 2024.   Further information will be provided in due course.

https://www.globenewswire.com/news-release/2024/01/23/2813983/0/en/Theratechnologies-Receives-Update-from-FDA-on-Tesamorelin-F8-Supplemental-Biologic-License-Application.html