CHMP positive opinion for AKEEGA® (niraparib and abiraterone acetate dual action tablet) for metastatic HSPC with BRCA1/2 mutations February 1, 2026
Imfinzi perioperative regimen recommended for approval in the EU by CHMP for patients with early gastric and gastroesophageal cancers February 1, 2026
ENHERTU + Pertuzumab Type II Variation Application Validated in the EU in 1L HER2+ve Metastatic Breast Cancer January 25, 2026
FDA sets draft rules for using MRD for supporting accelerated approvals in multiple myeloma January 25, 2026
US FDA Clears Two IND Applications, Enabling Ph 1 Trial of D3S‑003 and Ph 2 Combo Study of Elisrasib (D3S‑001) with D3S‑002 January 25, 2026
Regulatory Discussions with FDA on Potential Resubmission Path for ANKTIVA® in BCG-Unresponsive Papillary Bladder Cancer Advanced January 25, 2026
Sofetabart mipitecan receives US FDA Breakthrough Therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer January 25, 2026
FDA Grants Breakthrough Therapy Designation to WU-CART-007 for Treatment of R/R T-ALL/LBL January 25, 2026
Orphan Drug Designation Granted to OPN-2853 (Zavabresib) for the Treatment of Myelofibrosis January 25, 2026
FDA grants Orphan Drug Designation Granted to NP-G2-044 for the Treatment of Pancreatic Cancer January 18, 2026
BLA submitted to US FDA Seeking Approval for Ivonescimab + chemo Combo in 2L+ EGFRm NSCLC January 18, 2026
