Accelerated FDA Strategy to Advance (Z)-Endoxifen Across Breast Cancer Continuum Announced December 9, 2025
IND Clearance and EMA Approval of CTA for Ph 1/2 QUADvance Study of AVC-203 for R/R B-cell malignancies announced December 9, 2025
NICE Recommends AUCATZYL® (obecabtagene autoleucel) as a Treatment Option for Adult Patients with R/R B-ALL December 2, 2025
HREC provides human ethics approval for HARNESS-1 Ph 1a/b trial of RC220 in patients with EGFR-mutated NSCLC December 2, 2025
BLA Approval of Fucaso (Equecabtagene Autoleucel) by the Hong Kong Department of Health for the Treatment of R/R Multiple Myeloma Announced December 2, 2025
FDA Grants Fast Track Designation to Zotiraciclib for Treatment of Recurrent High-Grade Glioma with IDH1/2 Mutations December 2, 2025
Fast Track Designation for AVZO-103 for the Treatment of Patients with Urothelial Cancer Previously Treated with Enfortumab Vedotin December 2, 2025
FDA approves label update for UNLOXCYT™ (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced CSCC December 2, 2025
Gedatolisib NDA submission to FDA in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer completed November 24, 2025
FDA aligned on the design of pivotal study of pelareorep + SOC for 1L treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) November 24, 2025
FDA Accepts NDA for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC November 24, 2025
Rolling Submission of NDA to FDA initiated for Zipalertinib for Treatment of Locally Advanced or Metastatic NSCLC with EGFR Exon 20 Insertion Mutations November 24, 2025
NDA accepted; PDUFA Date announced for n.c.a. 177Lu-edotreotide (ITM-11) in GEP-NETs November 18, 2025
MHRA Approves CTA for YntraDose™ in unresectable Locally Advanced Pancreatic Cancer (uLA-PDAC) November 18, 2025
