Theratechnologies Submits Updated Tesamorelin F8 Formulation sBLA for FDA Review
Theratechnologies Inc. - Common Shares (THTX)
Company Research
Source: GlobeNewswire
Resubmission addresses questions raised in January 2024 Complete Response Letter F8 formulation intended to replace EGRIFTA SV® with simplified dosing for the treatment of excess abdominal fat in adults with HIV and lipodystrophy MONTREAL, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced the resubmission of its supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the F8 formulation of tesamorelin, the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. Theratechnologies has filed the resubmission to address concerns raised in the FDA’s Complete Response Letter (CRL) to the initial F8 formulation sBLA filing. In the CRL, which was issued in January 2024, the FDA requested clari
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News
- Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing Environment [Canadian Business Journal (Canada)]Canadian Business Journal
- Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing EnvironmentGlobeNewswire
- Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA [Canadian Business Journal (Canada)]Canadian Business Journal
- Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLAGlobeNewswire
- Theratechnologies Announces Preliminary Tolerability and Efficacy Data from Phase 1b, Dose-Ranging Trial of Sudocetaxel Zendusortide in Patients with Advanced Ovarian Cancer [Yahoo! Finance]Yahoo! Finance
THTX
Sec Filings
- 12/19/24 - Form 6-K
- 12/12/24 - Form 6-K
- 12/11/24 - Form 6-K
- THTX's page on the SEC website