European Commission granted Orphan Drug Designation to UCART22 for the treatment of ALL June 11, 2024
Fast Track Designation Granted by the FDA for Lunresertib in Combination with Camonsertib for the Treatment of Platinum-Resistant Ovarian Cancer June 11, 2024
FDA clears IND for Ph 1/2a trial (TCX-101) of BSB-1001 for patients with R/R AML, ALL and MDS, in conjunction with alloHSCT June 11, 2024
IND Filing for PFL-002/VERT-002 for Patients with Solid Tumors Including NSCLC with MET Alterations June 11, 2024
FDA Approved Ph 2/3 Study of KPG-121 + Abiraterone combination as 1L Treatment for metastatic CRPC June 11, 2024
Ph 3 pivotal Namodenoson HCC study recruiting in medical centers in Europe, Israel and the US June 11, 2024
FDA approves zolbetuximab BLA resubmission for 1L locally advanced unresectable or metastatic CLDN18.2+ve HER2-neg gastric or GEJ adenocarcinoma; new PDUFA: Nov 9, 2024 June 4, 2024
FDA Grants Orphan Drug Designation for CAN-3110 for the Treatment of Recurrent High-Grade Glioma June 4, 2024
FDA grants RMAT designation to TSC-100 & TSC-101 for the treatment of patients with AML, ALL, and MDS undergoing allogeneic HCT with reduced intensity conditioning June 4, 2024
Ph 2/3 TEBE-AM trial converted into registrational Ph 3 trial of KIMMTRAK for previously treated advanced cutaneous melanoma June 4, 2024
Sarclisa Accepted For FDA Priority Review For The Treatment Of Transplant-Ineligible Newly Diagnosed Multiple Myeloma June 4, 2024
FDA grants Fast Track Designation for Combination Therapy of AFM24 with Atezolizumab for EGFR WT NSCLC June 4, 2024
FDA grants Priority Review to inavolisib for advanced HR+ve, HER2-neg breast cancer with a PIK3CA mutation June 4, 2024
FDA Grants Priority Review to Supplemental BLA for KEYTRUDA + Chemo as 1L Treatment of Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma June 4, 2024
MHRA approves expansion of ModiFY trial; Modi-1 to be assessed in RCC in combination with double CPIs May 31, 2024
FDA Updates Action Date for Subcutaneous Nivolumab (nivolumab and hyaluronidase); new PDUFA: December 29, 2024 May 29, 2024
FDA grants Breakthrough Therapy Designation to inavolisib for advanced HR-positive, HER2-negative breast cancer with a PIK3CA mutation May 29, 2024
NMPA of China Accepted and Granted Priority Review Designation to the NDA for Glecirasib May 29, 2024
Fast Track Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Metastatic Pancreatic Cancer May 29, 2024
