FDA Grants RMAT Designation for Detalimogene in High-Risk, Non-Muscle Invasive Bladder Cancer July 1, 2025
FDA grants Fast Track Designation for SGR-1505 for the Treatment of R/R Waldenström Macroglobulinemia July 1, 2025
Update on U.S. Regulatory Review of TALZENNA in Combination with XTANDI for Broader Use in Metastatic CRPC Provided June 25, 2025
FDA Breakthrough Therapy Designation for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer with KRAS G12 Mutations June 24, 2025
FDA grants Orphan Drug Designation to ADoBind MC001 for the treatment of pancreatic cancer June 24, 2025
Breakthrough Therapy Designation application for oral gallium maltolate (GaM) in refractory brain tumors voluntarily withdrawn and resubmitted June 24, 2025
Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma June 24, 2025
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
