Feb 19, 2025 | Press Releases
Next-generation recombinant Bacillus Calmette-Guérin (rBCG) has undergone Phase 2 clinical trials in Europe in non-muscle invasive bladder cancer (NMIBC) Supplies of rBCG are now available, with shipments set to begin immediately via an FDA Expanded Access Program...
Feb 13, 2025 | Press Releases
CULVER CITY, Calif., February 13, 2025 – ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunity therapy company, today announced the Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for...
Jan 29, 2025 | Press Releases
Confirmatory trial builds on results of QUILT 3.055, a Phase 2 trial demonstrating ANKTIVA rescued T cells and activity of checkpoint inhibitors (CPIs) in patients with non-small cell lung cancer (NSCLC), who progressed on CPI therapies QUILT 3.055 showed prolonged...
Jan 27, 2025 | Press Releases
Application covers 30 countries in the European Union Submission is based on the ongoing QUILT 3.032 study in which 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS) have been treated...
Jan 15, 2025 | Press Releases
BCG unresponsive non-muscle invasive bladder cancer (NMIBC) in the papillary indication: Anticipated supplemental biologics license application (BLA) submission in 2025 Alternative source of BCG in partnership with Serum Institute of India: Anticipated submission for...
Jan 15, 2025 | Press Releases
Marketing authorization application for BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in situ (CIS) submitted to European Medicines Agency (EMA) in December 2024 and anticipated acceptance of application in 2025 Marketing authorization...