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
Vepdegestrant (ARV-471) Receives FDA Fast Track Designation for the Treatment of Patients with ER+/HER2- Metastatic Breast Cancer February 26, 2024
FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC) February 26, 2024
Supplemental BLA submitted to US FDA seeking approval of DARZALEX FASPRO)-based regimen for treatment of patients with transplant-eligible, newly diagnosed multiple myeloma February 26, 2024
Type II Extension of Indication Application to the EMA Seeking Approval of RYBREVANT + Lazertinib, for 1L Treatment of Patients with EGFR-Mutated NSCLC February 26, 2024
EMA Validates Type II Variation Application for PADCEV (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for 1L Treatment of Advanced Bladder Cancer February 26, 2024
PADCEV™ (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) Granted Priority Review by Japan’s MHLW for 1L Treatment of Advanced Bladder Cancer February 26, 2024
BLA for LYMPHIR™ (Denileukin Diftitox) For The Treatment Of Adults With R/R CTCL resubmitted February 26, 2024
U.S. and EU Regulatory Filings for Neoadjuvant Opdivo and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable NSCLC accepted February 26, 2024
U.S. FDA ODAC Meeting for Abecma in Triple-Class Exposed Multiple Myeloma Based on KarMMa-3 Study February 26, 2024
FDA Accepts for Priority Review Supplemental NDA for Augtyro™ (repotrectinib) for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors February 26, 2024
Datopotamab deruxtecan BLA accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer February 26, 2024
FDA accepted for Priority Review the BLA for linvoseltamab for R/R multiple myeloma that has progressed after at least three prior therapies February 26, 2024
FDA accepts Supplemental NDA for KRAZATI® (adagrasib) – Cetuximab combo for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or mCRC February 26, 2024
Positive EU CHMP Opinion for KEYTRUDA in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for the Treatment of Resectable NSCLC at High Risk of Recurrence February 26, 2024
Orphan Drug Designation Granted by US FDA for IO-202 (Anti-LILRB4) for the Treatment of Chronic Myelomonocytic Leukemia (CMML) February 26, 2024
