FDA Fast Track Designation for PLN-101095 in Combination with Pembrolizumab for the Treatment of ICI-Refractory Solid Tumors August 25, 2026
FDA clears IND application for C-CAR039 (Prizloncabtagene Autoleucel or Prizlon-cel) for the treatment of R/R LBCL August 20, 2026
FDA Fast Track designation for spevatamig in advanced and metastatic biliary tract carcinoma August 20, 2026
US FDA Type C Statistical Methods Meeting Granted to Review 2.5-Year OS Data for OST-HER2 in Metastatic Osteosarcoma August 20, 2026
Planned August sNDA Submission for Selinexor + Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track August 20, 2026
NMPA clears Ph 3 study of mesutoclax (ICP-248) + azacitidine versus venetoclax with azacitidine in elderly or unfit 1L AML patients August 20, 2026
FDA clears IND application to proceed to Ph 1/2 clinical trial for XTX501 in solid tumors August 20, 2026
FDA Grants Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer August 20, 2026
CRL issued for ongoing ITM-11 NDA citing CMC and third-party commercial facility inspection-related items August 11, 2026
Olomorasib receives FDA Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer August 5, 2026
FDA Clearance to Initiate TEMPO-1 Registrational Study of CRB-701 in Patients with 2L Oropharyngeal Cancer Announced August 5, 2026
RYBREVANT FASPRO (amivantamab & hyaluronidase-lpuj) receives FDA Priority Review for EGFR- & MET-targeted subQ treatment for advanced head and neck cancer August 5, 2026
IND Application for Ph 1b/2 Opamtistomig Combo in Metastatic Colorectal Cancer Approved August 5, 2026
FDA Grants Orphan Drug Designation to Zocilurtatug Pelitecan (Zoci) for the Treatment of Neuroendocrine Carcinomas (NECs) August 5, 2026
FDA RMAT Designation for Cemacabtagene Ansegedleucel (Cema-Cel) as 1L Consolidation Therapy for LBCL August 5, 2026
Supplemental NDA submission for Selinexor Plus Ruxolitinib in Myelofibrosis Planned Under Accelerated Approval Pathway August 5, 2026
