Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for GIST Patients February 1, 2026
FDA Orphan Drug Designation for CTD402 for the Treatment of T-Cell Leukemia and Lymphoma February 1, 2026
FDA Accepts BLA for Ivonescimab + Chemo in EGFRm NSCLC Post-TKI Therapy; PDUFA Nov 2026 February 1, 2026
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
