FDA Accepts for Priority Review Application for Opdivo + Cisplatin-Based Chemo for the 1L Treatment of Adult Patients with Unresectable/Metastatic urothelial carcinoma December 11, 2023
FDA granted “Fast-Track” Designation for Novel Armed Nanocell Drug Conjugate (ANDC) Pancreatic Cancer Therapeutic EDV (EnGeneIC Dream Vector) December 11, 2023
Positive EU CHMP Opinion for KEYTRUDA Plus Gemcitabine and Cisplatin as 1L Treatment for Locally Advanced Unresectable or Metastatic Biliary Tract Cancer December 4, 2023
US FDA Accepts for Priority Review Application for Breyanzi (lisocabtagene maraleucel) for R/R CLL/SLL December 4, 2023
FDA granted BTD and EMA application validated for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of R/R Follicular Lymphoma December 4, 2023
2nd Independent Safety Review of the ASPIRE Registration Clinical Trial Announced: Recommended Continuation with no Trial Modification December 4, 2023
U.S. FDA Fast Track Designation for BI 764532 for the Potential Treatment of Advanced or Metastatic Large-Cell Neuroendocrine Carcinoma of the Lung December 4, 2023
Supplemental BLA submitted to US FDA for obecabtagene autoleucel (obe-cel) for Patients with R/R Adult B-Cell ALL December 4, 2023
U.S. FDA Fast Track Designation for Zotatifin in Combination with Fulvestrant and Abemaciclib for Treatment of ER+/HER2- Advanced Metastatic Breast Cancer December 4, 2023
FDA Grants Priority Review to Supplemental BLA for KEYTRUDA Plus PADCEV for the 1L Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer December 4, 2023
Subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types December 4, 2023
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
