FDA clears IND application for ART-101 for the imaging and treatment of prostate cancer June 24, 2025
Zepzelca® (lurbinectedin) and Tecentriq Combination Granted U.S. FDA Priority Review for First-Line Maintenance Treatment of Extensive-Stage SCLC June 17, 2025
Breakthrough Therapy Designation Granted for Sacituzumab Tirumotecan (Sac-TMT) in Combination With Tagitanlimab in China for Certain Types of NSCLC June 17, 2025
Nadunolimab awarded US FDA Fast Track Designation for the treatment of patients with metastatic PDAC with high IL1RAP expression levels June 17, 2025
FDA authorizes Expanded Access Program for MNPR-101-Zr and MNPR-101-Lu in Advanced Cancers June 17, 2025
CHM CDH17 granted Fast Track for gastroenteropancreatic neuroendocrine tumours (GEP-NETs) June 11, 2025
NDA submitted to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer June 11, 2025
Tempest Receives Orphan Drug Designation from the EMA for Amezalpat for the Treatment of Patients with HCC June 10, 2025
Positive opinion for Orphan Medicinal Product Designation in the EU for GLIX1 in glioma June 10, 2025
FDA Breakthrough Therapy Designation granted to Iopofosine I 131 in Waldenstrom Macroglobulinemia (WM) June 10, 2025
FDA Orphan Drug Designation granted to MVdeltaC for the treatment of pleural mesothelioma June 10, 2025
Sevabertinib (BAY 2927088) granted FDA Priority Review for the treatment of patients with HER2-mutant NSCLC June 3, 2025
Patritumab Deruxtecan BLA for Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated NSCLC Voluntarily Withdrawn June 3, 2025
FDA clears IND application for ERAS-4001 for the treatment of patients with KRAS-mutant (KRASm) solid tumors June 3, 2025
FDA Accepts and grants Priority Review of NDA for Ziftomenib in Adults with R/R NPM1-Mutant AML June 3, 2025
FDA grants Regenerative Medicine Advanced Therapy (RMAT) Designation for CAN-2409 for the Treatment of Prostate Cancer June 3, 2025
Imfinzi recommended for approval in the EU by CHMP as perioperative immunotherapy for MIBC June 3, 2025
MAA submitted to the EMA for Zepzelca® (lurbinectedin) + Tecentriq for the maintenance treatment of adult patients with ES-SCLC May 27, 2025
