Posted by Michael Wonder on 26 Jan 2024
Theratechnologies receives complete response letter from the FDA for the F8 formulation of tesamorelin sBLA
24 January 2024 - FDA requesting clarifications around chemistry, manufacturing and controls and additional information related to immunogenicity.
Theratechnologies today announced that the US FDA has issued a complete response letter in response to the Company’s supplemental biologics license application for the F8 formulation of tesamorelin.
