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
BLA submission planned in Q4 2025 for Ivonescimab based on HARMONi Global Ph 3 Study Results October 29, 2025
Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Adjuvant Treatment of CSCC with a High Risk of Recurrence After Surgery and Radiation October 21, 2025
FDA Fast Track designation for OncoMimics™ immunotherapy EO2463 in follicular lymphoma October 21, 2025
US FDA Priority Review for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) in BRCA-mutated metastatic CSPC October 21, 2025
CTA Authorization and Initiation of Ph 0/1 Clinical Trial for TGW211 for the Treatment of HER2+ Tumors announced October 21, 2025
FDA feedback provided regarding the successful completion of Project Optimus requirements and agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti) October 21, 2025
VeraMorph Awarded an SBIR Fast Track Grant by NCI Towards Commercialization of the First Effective Oral Fulvestrant Therapy for ER+ Metastatic Breast Cancer October 21, 2025
FDA approves IND Application for Ph 2/3 Study of JS207 for the Neoadjuvant Treatment of NSCLC Patients October 21, 2025
Scemblix® receives positive CHMP opinion for the treatment of adults with newly diagnosed CML October 21, 2025
FDA Fast Track Designation for NG-350A for the Treatment of MMR-Proficient Locally Advanced Rectal Cancer October 18, 2025
Cinetredekin besudotox Granted FDA Orphan Drug Designation by US FDA for Treatment of GBM October 16, 2025
FDA Fast Track Designation for NG-350A for the Treatment of Mismatch Repair-Proficient Locally Advanced Rectal Cancer October 15, 2025
HREC approves initiation of FIH Ph 1/2 Trial of ML-016 in Advanced Cancers with Lung and/or Liver Involvement October 15, 2025
