FDA Fast Track Designation for CT-0525 for the Treatment of HER2-overexpressing Solid Tumors July 1, 2024
FDA grants Fast Track Designation for ABD-147 for the Treatment of Patients with Extensive-stage SCLC July 1, 2024
Odronextamab Recommended for EU Approval by the CHMP to Treat R/R Follicular Lymphoma and DLBCL July 1, 2024
Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with R/R Follicular Lymphoma July 1, 2024
EMA validates extension application for SC formulation for Opdivo including liquid formulation and new strength across previously approved indications June 25, 2024
China’s NMPA approves IND for GFH375 for Ph 1/2 Clinical Trial Treating Advanced Solid Tumor Patients with KRAS G12D Mutation June 25, 2024
Fast Track Designation from the U.S. FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer June 18, 2024
Tagrisso granted Priority Review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer June 18, 2024
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
