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
FDA Clears IND Application for Ph 1 Trial of RB-164 for Hematologic and Solid Malignancies April 2, 2025
US FDA Breakthrough Therapy Designation for Darovasertib Monotherapy in Neoadjuvant Uveal Melanoma April 2, 2025
Positive CHMP Opinion for Neoadjuvant Opdivo + Chemo Followed by Surgery and Adjuvant Opdivo for Resectable NSCLC in Patients with Tumor Cell PD-L1 Expression ≥1% April 2, 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP for 1L MCL April 2, 2025
FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient March 26, 2025
Second DSMB Issues Positive Recommendation to Continue Bria-IMT Ph 3 Study in Metastatic Breast Cancer March 26, 2025
FDA Clears IND Application for Combination of Versamune® MUC1 and PDS01ADC to Treat Metastatic CRC March 18, 2025
Update relating to Resminostat’s (Kinselby) Marketing Authorisation Application announced March 18, 2025
