Posted by Michael Wonder on 27 Feb 2024
Theratechnologies receives refusal to file letter for Trogarzo intramuscular method of administration sBLA from FDA
27 February 2024 - Theratechnologies today announced that the US FDA has issued a refusal to file letter regarding the Company’s supplemental biologics license application for an intramuscular method of administration for the maintenance dose of Trogarzo (ibalizumab-uiyk).
The filing was announced on 2 January 2024.
