BLA submission of ANKTIVA planned in 2025 for 2/3L treatment of patients with NSCLC, who are progressing on checkpoint inhibitors January 21, 2025
Datopotamab deruxtecan granted Priority Review in the US for patients with previously treated advanced EGFR-mutated NSCLC January 15, 2025
FDA clears IND for Ph 1/2 clinical trial of REC-4539 in SCLC and MHRA clears IND for Ph 1 clinical trial of REC-3565 for B-cell malignancies January 15, 2025
US FDA Breakthrough Therapy Designation Granted to Letetresgene Autoleucel (lete-cel) for Treatment of Myxoid/Round Cell Liposarcoma (MRCLS) January 15, 2025
GSK’227 receives US FDA Breakthrough Therapy Designation in late-line R/R osteosarcoma January 15, 2025
Invikafusp Alfa (STAR0602) Receives US FDA Fast Track Designation for Treatment of Unresectable, Locally Advanced, or Metastatic TMB-H CRC January 15, 2025
IND submission for NDI-219216 completed with plans to initiate clinical trial in 1H 2025 for treatment of MSI-H tumors January 15, 2025
Supplemental NDA for cabozantinib in pNET and epNET patients no longer the subject of discussion at an ODAC meeting January 15, 2025
Azenosertib Fast Track Designation granted for Cyclin E1 positive patients by US FDA January 15, 2025
Novel CPT1 pathway inhibitor received Orphan Drug Designation from the FDA for treating malignant gliomas January 15, 2025
ELC-100 receives Orphan Drug Designation in the U.S. for the treatment of pancreatic neuroendocrine tumors January 15, 2025
