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
Positive feedback from MHRA provides alignment on the preclinical, manufacturing, clinical & regulatory pathway for ZI-MA4-1 and supports planned CTA submission October 15, 2025
Ficerafusp Alfa Granted Breakthrough Therapy Designation by US FDA for 1L HPV-Negative R/M HNSCC October 15, 2025
FDA Fast Track Designation to WTX-124 for locally advanced or metastatic cutaneous melanoma after SOC immunotherapy October 15, 2025
FDA Fast Track Designation Granted to ADCE-D01 for the Treatment of Soft Tissue Sarcoma October 15, 2025
FDA Accepts BLA for Priority Review for Orca-T® to Treat Heme Malignancies; PDUFA date April 6, 2026 October 8, 2025
