Positive EU CHMP Opinion for KEYTRUDA + Chemo as 1L Treatment for HER2-Negative Advanced GEJ Adenocarcinoma Expressing PD-L1 (CPS ≥1) October 16, 2023
U.S. FDA Fast Track Designation for KT-333 for the Treatment of R/R Cutaneous T-Cell Lymphoma and R/R Peripheral T-Cell Lymphoma October 11, 2023
FDA Grants Priority Review to KEYTRUDA + Concurrent ChemoRT as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer October 11, 2023
FDA Accepts for Priority Review Supplemental NDA for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced RCC October 11, 2023
Odronextamab BLA for Treatment of R/R Follicular Lymphoma (FL) and DLBCL Accepted for FDA Priority Review October 3, 2023
Fast Track Designation for IDE161, for Treatment of Pretreated, Platinum-Resistant Advanced or Metastatic Ovarian Cancer Patients with BRCA1/2 Mutations October 3, 2023
Fast Track Designation for IDE161 for the Treatment of Pretreated, Advanced or Metastatic HR+, HER2-, BRCA1/2 mutant Breast Cancer October 3, 2023
FDA grants Fast Track Designation to MYTX-011 for Patients with NSCLC with cMET Overexpression October 3, 2023
FDA Accepts for Priority Review Supplemental NDA for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced RCC September 26, 2023
U.S. FDA Fast Track Designation for KT-333 for the Treatment of R/R Cutaneous T-Cell Lymphoma and R/R Peripheral T-Cell Lymphoma September 26, 2023
FDA Grants Priority Review to KEYTRUDA + Concurrent ChemoRT as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer September 26, 2023
Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3-ITD Positive AML September 19, 2023
Enhertu recommended for approval in the EU by CHMP for patients with HER2-mutant advanced NSCLC September 19, 2023
Positive EU CHMP Opinion for KEYTRUDA as Adjuvant Treatment for Adults with NSCLC at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemo September 19, 2023
