Theratechnologies announced that the U.S. Food and Drug Administration, FDA, has assigned a Prescription Drug User Fee Act, PDUFA, goal date of January 22, 2024 to the Company’s supplemental Biologics License Application, sBLA, of the F8 formulation of tesamorelin. In accordance with the FDA’s standard review practices, unless the Company is notified before November 21, 2023, that the application is not sufficiently complete to permit a substantive review, the FDA will file the sBLA for the F8 formulation of tesamorelin.
Meet Your ETF AI Analyst
- Discover how TipRanks' ETF AI Analyst can help you make smarter investment decisions
- Explore ETFs TipRanks' users love and see what insights the ETF AI Analyst reveals about the ones you follow.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See Insiders’ Hot Stocks on TipRanks >>
Read More on THTX:
- Theratechnologies Receives January 2024 PDUFA Goal Date for Tesamorelin F8 Formulation sBLA
- Theratechnologies price target lowered to C$5.50 from C$7 at National Bank
- Theratechnologies Reports Financial Results for the Third Quarter and Nine Months of Fiscal 2023 and Provides Business Updates
- Theratechnologies adjusted FY23 revenue view to $82M-$85M from $82M-$87M
- Theratechnologies reports Q3 revenue $20.855M, consensus $21.05M