BLA submitted to U.S. FDA for Talquetamab for the Patients with R/R Multiple Myeloma December 12, 2022
FDA Fast Track Designation to pelareorep + atezolizumab + chemo in Advanced/Metastatic Pancreatic Cancer December 5, 2022
U.S. indication of Tecentriq® for the treatment of cisplatin-ineligible, PD-L1+ve adults with locally advanced or mUC to be withdrawn December 5, 2022
FDA accepts BLA of Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma December 5, 2022
FDA Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010 December 5, 2022
U.S. FDA Accepts for Priority Review the BLA for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of R/R Large B-Cell Lymphoma November 30, 2022
FDA issued CRL indicating the poziotinib application cannot be approved in its present form; company to deprioritise the program November 30, 2022
FDA Clears IND Application for BCMA CAR-T CB-011 for the Treatment of R/R Multiple Myeloma November 30, 2022
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive advanced gastric cancer November 23, 2022
Lynparza – abiraterone combo recommended for approval in the EU by CHMP in 1L metastatic CRPC November 23, 2022
Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer November 23, 2022
FDA restricted 2L maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious gBRCAmut November 23, 2022
Innovation Passport Designation granted to Biologic CAR T-Cell Therapy Engager ALETA-001 November 16, 2022
Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML November 2, 2022
FDA clears IND for LYL845, a TIL Product Candidate Enhanced with its Novel Epigenetic Reprogramming Technology for Solid Tumors November 2, 2022
BLAs for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of R/R LBCL and DLBCL submitted November 2, 2022
U.S. FDA Accepts For Priority Review Supplemental BLA For Trodelvy® For Pre-Treated HR+/HER2- Metastatic Breast Cancer October 19, 2022
US FDA grants Fast Track Designation for SHP2 inhibitor BBP-398 in Combination with LUMAKRAS® (sotorasib) October 19, 2022
Positive Pre-NDA Meeting for Rivoceranib Combination With Camrelizumab as Hepatocellular Carcinoma Treatment Option Announced October 19, 2022
