FDA clears IND application for ORM-1153 for Ph 1 study in patients with R/R AML and other hematologic malignancies August 25, 2026
FDA Fast Track Designation Granted to ERAS-0015 in Patients with Metastatic Pancreatic Adenocarcinoma August 25, 2026
Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally advanced rectal cancer August 25, 2026
FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study August 25, 2026
FDA Fast Track Designation for BH-30643 for the Treatment of Advanced EGFR C797S-positive NSCLC August 25, 2026
FDA Fast Track Designation for ETX-19477 for the Treatment of Patients with BRCA-Mutated, HR+/HER2- Unresectable or Metastatic Breast Cancer August 25, 2026
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
