CHMP recommends EU approval of Itovebi for PIK3CA-mutated, ER+ve, HER2-neg, advanced breast cancer May 27, 2025
FDA ODAC votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma May 27, 2025
NMPA CDE grants Breakthrough Therapy Designation for Irpagratinib (ABSK011) in the Treatment of HCC May 27, 2025
Positive CHMP Opinion for Obecabtagene Autoleucel for Adult Patients (age 26 and older) with R/R B-ALL May 27, 2025
FDA ODAC Votes Against Risk/Benefit Profile of UGN-102 in Recurrent, Low-Grade, Intermediate-Risk NMIBC May 27, 2025
FDA ODAC Votes Against the Applicability of STARGLO Data for Glofitamab + Chemo for Patients With R/R DLBCL May 27, 2025
EMA approves CTA to conduct pivotal Ph 2B/3 trial of Annamycin + cytarabine in R/R AML patients May 21, 2025
U.S. FDA granted Fast Track Designation for ZL-1310 for Treatment of Extensive-Stage SCLC May 21, 2025
IND application for Ph 1 trial of Penetrium™ in combination with docetaxel voluntary withdrawn May 21, 2025
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
