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
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
