FDA issues a CRL for linvoseltamab’s BLA in R/R multiple myeloma that has progressed after at least three prior therapies August 27, 2024
FDA grants Breakthrough Therapy Designation to GSK5764227 for R/R extensive-stage SCLC August 27, 2024
TROP2-ADC SKB264 (sac-TMT) Second NDA Accepted by NPMA for locally advanced or metastatic EGFR-mutant NSCLC August 27, 2024
Human Research Ethics Committee (HREC) in Australia clears initiation of Ph 1 trial of MNPR-101-Lu August 27, 2024
FDA granted Fast Track Designation to APG-157 for the neoadjuvant treatment of Head and Neck Cancer (HNC) August 27, 2024
Imfinzi granted Priority Review and Breakthrough Therapy Designation for patients with limited-stage SCLC in the US August 22, 2024
ENHERTU® Granted Breakthrough Therapy Designation in U.S. for Certain Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer August 22, 2024
FDA Clears IND Application for Ph 1b Study of PTM-101 for the Localized Treatment of Pancreatic Cancer August 22, 2024
BRG01 Receives FDA Approval for Ph 2 Trial for the treatment of relapsed/metastatic EBV-positive NPC August 22, 2024
ENHERTU Type II Variation Application Validated by EMA for Patients with HER2 Low or Ultralow Metastatic Breast Cancer Following At Least One Endocrine Therapy August 22, 2024
FDA granted Fast Track designation to Deltacel™ (KB-GDT-01) Gamma Delta T-cell (GDT) therapy August 22, 2024
Successful End-of-Phase 2 Meeting with FDA for Amezalpat (TPST-1120) to Treat 1L HCC Announced August 22, 2024
Ph 3 SIERRA trial deemed inadequate to support BLA filing for Iomab-B; additional head-to-head RCT demonstrating OS benefit required August 22, 2024
FDA Clears IND Application for Ziftomenib in Advanced Gastrointestinal Stromal Tumors (GIST) August 13, 2024
FDA provides IND requirements for the development of ALA-101 in first-inhuman clinical trials for lymphoma and leukaemia August 13, 2024
FDA accepts Supplemental NDA for Cabozantinib for Patients with Advanced Neuroendocrine Tumors August 13, 2024
FDA grants “Study May Proceed” letter for the Ph 1/2 study of Silmitasertib (CX-4945) + chemo in children and young adults with R/R solid tumors August 13, 2024
Supplemental NDA of Opdivo – Yervoy Combo submitted in Japan to Expand the Use for Unresectable HCC August 13, 2024
