Supplemental BLA submitted to FDA Seeking Approval of RYBREVANT + Chemo in EGFRm NSCLC Patients Who Progressed on or after Osimertinib December 4, 2023
FDA Granted Fast Track Designation for ONCT-534 for the Treatment of Metastatic CRPC October 31, 2023
Resubmission of BLA for N-803 + BCG for the treatment of BCG-unresponsive NMIBC accepted; new PDUFA date of April 23, 2024 October 31, 2023
EMA accepted the MAA for mirvetuximab soravtansine (ELAHERE®) for the treatment of patients with FRα-positive, platinum-resistant epithelial ovarian cancer October 31, 2023
Tagrisso plus chemo granted Priority Review in the US for patients with EGFR-mutated advanced NSCLC October 25, 2023
Positive CHMP opinion recommending approval of Jemperli (dostarlimab) + chemo as 1L treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer October 25, 2023
BRUKINSA Receives Positive Recommendation from NICE in U.K. for Adult Patients with CLL October 25, 2023
Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL in the European Union October 25, 2023
Global Registrational Ph 3 Study of Lisaftoclax in 1L CLL/SLL Patients Approved by the China CDE October 25, 2023
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
