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
FDA Granted Fast Track Designation for AVZO-1418 for the Treatment of Patients with EGFR-Mutated TKI-Pretreated NSCLC November 18, 2025
FDA alignment secured on planned Ph 3 NDV-01 program in 2L BCG-unresponsive NMIBC patients and Intermediate risk NMIBC in the adjuvant setting November 10, 2025
GSK5764227 (GSK’227) received Orphan Drug Designation from EMA for the treatment of pulmonary NEC/SCLC November 4, 2025
FDA Meeting Requested to Seek Expedited Approval Pathway for PDS0101 in HPV16-Positive Head and Neck Cancer November 4, 2025
FDA grants non-transferrable voucher for daraxonrasib (RMC-6236) under the Commissioner’s National Priority Voucher (CNPV) pilot program October 29, 2025
Zenocutuzumab-zbco Granted FDA Breakthrough Therapy Designation for NRG1+ Cholangiocarcinoma October 29, 2025
FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX™, Each in Combination with Padcev, for Cisplatin-ineligible Patients with MIBC October 29, 2025
Rare Pediatric Disease Designation from FDA for Iopofosine I 131 in R/R Pediatric High-Grade Glioma October 29, 2025
Type C meeting with FDA requested to discuss OS findings in 1L GBM patients treated with paxalisib and to discuss potential regulatory pathway per OCE’s Project FrontRunner initiative October 29, 2025
