Gradalis Secures FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Vigil® (Gemogenovatucel-T) for Advanced Ovarian Cancer February 11, 2025
Positive Ziftomenib Monotherapy Registrational Trial and Positive FDA Feedback for Upcoming Frontline Combination Trial Designs Announced February 11, 2025
All clinical studies evaluating TIDAL-01 to discontinue and further development of the program halted February 11, 2025
US FDA Grants Orphan Drug Designation to 225Ac-SSO110 (satoreotide) for the treatment of patients with SCLC February 11, 2025
FDA feedback provided on potential ELI-002 Ph 3 study design, including dose, schedule, patient population and primary endpoint analysis January 28, 2025
BLA accepted, Priority Review granted for RP1 for the Treatment of Advanced Melanoma January 28, 2025
Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of SCLC January 28, 2025
FDA Clears 225Ac-Satoreotide Ph 1/2 Clinical Study in Patients with SCLC or Merkel Cell Carcinoma January 21, 2025
NDA initiated with US FDA for TAR-200 for patients with BCG-unresponsive high-risk NMIBC January 21, 2025
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
