Positive CHMP Opinions for TEVIMBRA® as a 1L Treatment for Advanced/Metastatic Gastric or GEJ Cancer and Esophageal Squamous Cell Carcinoma October 22, 2024
FDA Clears IND Application for Ph 1/2 ADCElerate-01 Trial of ADCE-D01 Trial in Patients with Metastatic and/or Unresectable Soft Tissue Sarcoma (STS) October 15, 2024
Type II variation application to the EMA for DARZALEX® (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients October 15, 2024
CRLs submitted to request lifting the clinical holds for zevorcabtagene autoleucel, satricabtagene autoleucel and CT071 October 15, 2024
Enhertu granted Priority Review in the US for patients with HER2-low/ultralow metastatic breast cancer who received at least one line of endocrine therapy October 8, 2024
Supplemental BLA filed for U.S. FDA approval of DARZALEX FASPRO®-based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned October 8, 2024
FDA Clears IND Application for REC-1245, a RBM39 Degrader for Biomarker-Enriched Solid Tumors and Lymphoma October 8, 2024
FDA IND Clearance for ALE.P02, a Novel CLDN1-ADC for the Treatment of Squamous Cancers October 8, 2024
ENHERTU® Supplemental NDA Submitted in Japan for Patients with HER2 Low/ultralow Metastatic Breast Cancer October 8, 2024
Calquence granted Priority Review in the US for patients with untreated mantle cell lymphoma October 8, 2024
Fast Track Designation from the FDA for EO-3021 for the Treatment of Adult Patients with Advanced or Metastatic Gastric or GEJ Cancer Expressing Claudin 18.2 October 2, 2024
BLA submitted for accelerated approval for Telisotuzumab Vedotin (Teliso-V) in Previously Treated NSCLC with c-Met protein overexpression based on Ph 2 LUMINOSITY trial (M14-239) data October 2, 2024
Positive Interim Ph 2 Data for Darovasertib and Successful FDA Type C Meeting on Registrational Trial Design for Regulatory Approval in Neoadjuvant Uveal Melanoma Announced October 1, 2024
Supplemental NDA submitted to FDA for darolutamide + ADT combo in patients with mHSPC October 1, 2024
FDA Advisory Committee Vote on Benefit-Risk Profile of PD-1 Inhibitors, including TEVIMBRA®, for Treatment of ESCC and Gastric/GEJ Cancers recommends a class-wide PD-L1 expression level cut-off across PD-1 inhibitors October 1, 2024
NDA Resubmitted to FDA for Camrelizumab + Rivoceranib for 1L Unresectable HCC Boosted by CARES-310 Leading OS Analysis October 1, 2024
Positive CHMP Opinion for Mirvetuximab Soravtansine (ELAHERE®) for the Treatment of Certain Adult Ovarian Cancer September 24, 2024
Blenrep (belantamab mafodotin) combinations in R/R multiple myeloma accepted for regulatory review in Japan September 24, 2024
