Orphan Drug Designation Granted by the U.S. FDA to Nana-val for the Treatment of Nasopharyngeal Carcinoma December 19, 2023
Application submitted to the EMA for RYBREVANT + Chemo for the Treatment of Adult Patients with Advanced EGFR-Mutated NSCLC After Failure of Prior Therapy December 11, 2023
FDA Grants Priority Review of Supplemental BLA for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer December 11, 2023
Both FDA Fast Track and Breakthrough Therapy Designation for Cretostimogene Grenadenorepvec in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer December 11, 2023
TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer December 11, 2023
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
