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
Rolling Submission of NDA to FDA initiated for Seeking Accelerated Approval of Avutometinib and Defactinib Combination for the Treatment of Adult Patients with Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer May 29, 2024
US FDA accepts Protocol for New Randomized Ph 2 Study of NBTXR3 for Patients with Stage 3 Lung Cancer May 21, 2024
China CDE Clearance for Ph 3 Trial of KRAS G12C Inhibitor Glecirasib in Patients with CRC Announced May 21, 2024
Paediatric Investigation Plan Waiver Received from the European Medicines Agency for Certepetide in Pancreatic Cancer May 21, 2024
FDA Grants Type B End-of-Phase 2 Meeting to Discuss BOT/BAL Therapy for R/R Metastatic CRC May 21, 2024
U.S. FDA Accepts and grants Priority Review of BLA for Zeno for the Treatment of NRG1+ NSCLC and PDAC May 15, 2024
