Certepetide Granted FDA Orphan Drug Designation for the Treatment of Cholangiocarcinoma September 10, 2024
Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of ARID1a-deficient Ovarian, Fallopian Tube, and Primary Peritoneal Cancers September 3, 2024
Supplemental NDA for fruquintinib + paclitaxel for treatment of 2L advanced gastric or GEJ adenocarcinoma voluntarily withdrawn in China September 3, 2024
CDE of NMPA Approves to Initiate Ph 3 Trial of 9MW2821 for Urothelial Carcinoma in Combination with PD-1 Inhibitor September 3, 2024
NMPA approves Supplemental BLA for Carteyva® in Adult Patients with R/R Mantle Cell Lymphoma September 3, 2024
FDA accepts Supplemental BLA for 1L HCC based on Ph 3 CheckMate -9DW trial demonstrating improved survival with Opdivo + Yervoy vs SoC; PDUFA: Apr 2025 August 27, 2024
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
