Theratechnologies submits updated tesamorelin F8 formulation sBLA for FDA review

Theratechnologies

26 November 2024 - Resubmission addresses questions raised in January 2024 complete response letter.

Theratechnologies today announced the resubmission of its supplemental biologics license application to the US FDA for the F8 formulation of tesamorelin, the only medication approved in the US for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.

Read Theratechnologies press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier