CHMP adopts positive opinion for BALVERSA (erdafitinib) in unresectable/metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations July 9, 2024
NMPA accepts NDA for Tazemetostat for the Treatment of R/R Follicular Lymphoma with Priority Review Status July 9, 2024
Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for patients with MMR-proficient advanced or recurrent endometrial cancer July 9, 2024
FDA Granted Fast Track Designation for 225Ac-FL-020 for the Treatment of Metastatic CRPC July 9, 2024
Patritumab Deruxtecan BLA Submission Receives CRL from FDA Due to Inspection Findings at Third-Party Manufacturer July 1, 2024
FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric ALL July 1, 2024
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
