FDA Clearance obtained for a First in Human Clinical Study for Stage III/IV Ovarian Cancer Treatment with Autologous Vaccine Therapy, Innocell™ March 12, 2024
IMBRUVICA® (ibrutinib) Label expanded in the U.S. to Include Oral Suspension Formulation for Adult Patients in its Approved Indications March 12, 2024
Application submitted to the EMA for DARZALEX® (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma March 12, 2024
Two Datopotamab Deruxtecan Applications Validated in the EU for Patients with Advanced Nonsquamous NSCLC or HR+, HER2 Negative Breast Cancer March 12, 2024
Positive CHMP Opinion for CARVYKTI in Patients with Relapsed and Lenalidomide-Refractory Multiple Myeloma in Earlier Lines of Therapy March 5, 2024
U.S. FDA Breakthrough Therapy Designation for BAY 2927088 for NSCLC Harboring HER2 Activating Mutations March 5, 2024
BLA for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA March 4, 2024
FDA Accepts for Priority Review the Supplemental BLA for Epcoritamab (EPKINLY®) for Difficult-to-Treat R/R Follicular Lymphoma March 4, 2024
US regulatory approval received to start pancreatic cancer Ph IIb trial with nadunolimab February 26, 2024
FDA Grants Priority Review to Supplemental BLA for KEYTRUDA Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma February 26, 2024
Orphan Drug Designation Granted to Soquelitinib for the Treatment of T Cell Lymphoma February 26, 2024
Approval received to initiate clinical Ph 1/2-study CARMA with CAR T-cell therapy ELC-301 in B-Cell lymphoma February 26, 2024
Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours February 26, 2024
Regulatory Applications Accepted in the U.S. and Japan for Breyanzi (lisocabtagene maraleucel) in R/R Follicular Lymphoma and R/R Mantle Cell Lymphoma February 26, 2024
FDA accepts BLA for Afami-cel for the Treatment of Advanced Synovial Sarcoma with Priority Review February 26, 2024
Tisotumab Vedotin MAA Validated by EMA for Treatment of Recurrent or Metastatic Cervical Cancer February 26, 2024
EMA Orphan Drug Designation for UV1 Cancer Vaccine for the Treatment of Mesothelioma February 26, 2024
