Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for 1L CLL May 6, 2025
CHMP Positive Opinion for Zanidatamab for the Treatment of Advanced HER2-Positive Biliary Tract Cancer April 30, 2025
FDA clears IND application for VS-7375, Enabling Ph 1/2a Trial in Advanced Solid Tumors April 30, 2025
EMA gives IMPD approval to initiate Ph 1 trial of OT-C001 + Rituximab in DLBCL patients April 30, 2025
FDA Clears IND Application for Ph 2 Trial of HEPZATO™ in Liver-Dominant Metastatic Breast Cancer April 30, 2025
NMPA accepted NDA for zurletrectinib (ICP-723) for patients with advanced solid tumors harboring NTRK gene fusions April 22, 2025
Rare Pediatric Disease Designation for NEO100 in Treatment of Pediatric-Type Diffuse High-Grade Gliomas April 22, 2025
PTX-100 receives US FDA Fast Track Designation for the treatment of adults with R/R mycosis fungoides, the most common subtype of CTCL April 22, 2025
Supplemental BLA submitted to FDA for use of ANKTIVA® plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease April 22, 2025
NDA submitted to the US FDA for ziftomenib in adult patients with R/R AML with NPM 1 mutation April 16, 2025
FDA Clears IND Application for Ph 1 Trial of RB-164 for Hematologic and Solid Malignancies April 8, 2025
FDA clears IND application for ALX2004 for the treatment of EGFR-expressing solid tumors April 8, 2025
Ph 3 Study Design Finalized with FDA for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer April 2, 2025
Positive CHMP Opinion for the SC Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications April 2, 2025
