Urgent Meeting With FDA Requested to Address the Change in the Agency’s Unambiguous Guidance to Submit Supplemental BLA for NMIBC BCG Unresponsive Papillary Disease, Following an Inconsistent Refusal to File Letter May 13, 2025
CHMP recommends EU label update for Phesgo to allow administration outside of clinical settings May 6, 2025
FDA Fast Track Designation for INX-315 to Treat CCNE1-Amplified Platinum-Resistant/Refractory Ovarian Cancer May 6, 2025
Supplemental BLA submission to FDA for Epcoritamab + Rituximab and Lenalidomide (R2) in Patients with R/R Follicular Lymphoma planned May 6, 2025
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
