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
FDA clears IND application for BA3361, a CAB-Nectin-4 Antibody Drug Conjugate for the Treatment of Multiple Tumors May 14, 2024
China NMPA Grants IND Clearance for ADRX-0706, a Novel Nectin-4 ADC for the Treatment of Advanced Solid Tumors May 14, 2024
US FDA accepts for priority review Supplemental BLA of Jemperli (dostarlimab) + chemo to include all adult patients with primary advanced or recurrent endometrial cancer May 1, 2024
FDA Fast Track Designation for the Investigation of CTX-009 in Combination with Paclitaxel for the Treatment of Previously-treated Patients with Metastatic or Locally Advanced Biliary Tract Tumors May 1, 2024
FDA Approves GFH925 (KRAS G12C Inhibitor) Monotherapy trial in Ph 3 Registrational Study Treating Metastatic CRC May 1, 2024
FDA Clears IND Application for Novel SIGLEC 10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors May 1, 2024
