FDA Clears IND for Ph 1b/2 Trial of LP-184 in Biomarker-Defined, Treatment-Resistant NSCLC Patients with High Unmet Clinical Need May 21, 2025
IND cleared for ERAS-0015 and IND submitted for ERAS-4001; Ph 1 monotherapy data for both programs expected in 2026 May 21, 2025
FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation for B7-H3 CAR T-cell therapy for incurable pediatric brain tumors May 21, 2025
CPO301 granted the fast track designation by U.S. FDA for the treatment of adult patients with NSCLC May 21, 2025
IND Clearance obtained for Ph 1b/2 Trial of LP-184 + ICIs in NSCLC patients with KEAP1 and/or STK11 mutations and low PD-L1 expression May 13, 2025
Fast Track Designation for ADRX-0706 Nectin-4 ADC for the Treatment of Advanced Cervical Cancer May 13, 2025
FDA Advisory Committee Announced for UGN-102 for Recurrent Low-Grade Intermediate-Risk NMIBC May 13, 2025
FDA lifts the clinical hold on IND applications for the EBVALLO™ (tabelecleucel) program May 13, 2025
IND application submitted to the U.S. FDA for UTRxM1-18 for targeting c-MYC driven cancers May 13, 2025
US FDA grants Orphan Drug Designation to THE001 for the treatment of soft tissue sarcomas (STS) May 13, 2025
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
