AdaptimmuneAfter meeting the primary endpoints of a pivotal Phase II trial, UK-based Adaptimmune Ltd. is submitting an FDA Biologics License Application for its autologous T-cell receptor therapy (TCR-T) Lete-cel (letetresgene autoleucel).
Tag Archive for: FDA
Medilink TherapeuticsGood news for BioNTech SE: The safety study of the ADC BNT326/YL202 developed by MediLink Therapeutics, which was suspended by the FDA in mid-June, will continue.
German AdrenoMed AG has got FDA Fast Track designation for its targeted septic shock medicine enibarcimab that restores endothel integrity.
TME Pharma (France/Germany) announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for NOX-A12 (olaptesed pegol), TME Pharma’s CXCL12 inhibitor, in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer glioblastoma.
Following in the footsteps of the European Medicines Agency (EMA), the US FDA is now also investigating the side effects of obesity blockbusters.