The FDA has refused to review Theratechnologies’ supplemental Biologics License Application, seeking approval for an intramuscular formulation for the maintenance dose of its HIV therapy Trogarzo (ibalizumab-uiyk), the biotech announced on Tuesday.
Tag Archive for: Tesamorelin
The regulator’s Complete Response Letter flagged issues with the new formulation of tesamorelin’s chemistry, manufacturing and controls and sought more information about its immunogenicity risk.
After a quiet start to 2024, the FDA is expected to decide on three applications over the next two weeks, including one for a nasal powder migraine treatment.