BLA submitted to FDA for Cosibelimab as a Treatment for Patients with Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma January 11, 2023
BLA Review for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) by FDA remains pending January 4, 2023
Adagrasib (KRAZATI™) Receives Breakthrough Therapy Designation from FDA for Patients with Advanced, KRAS-Mutated CRC January 4, 2023
Positive follow-up Type C meeting with FDA regarding late-stage clinical development plans for eftilagimod alpha + SOC for the treatment of metastatic breast cancer (MBC) January 4, 2023
FDA Approves Clinical Trial Application for BCMA CAR-T CT103A for R/R Multiple Myeloma January 4, 2023
FDA Accepts Supplemental BLA for PADCEV® (enfortumab vedotin-ejfv) + KEYTRUDA for 1L Locally Advanced or Metastatic Urothelial Cancer patients January 4, 2023
Enhertu recommended for approval in the EU by CHMP for patients with HER2-low metastatic breast cancer January 4, 2023
Positive EMA Opinion on Orphan Designation for Ivospemin (SBP-101) + Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma December 19, 2022
PDUFA date extended by three months to review Lynparza + abiraterone & prednisone supplemental NDA for metastatic CRPC December 19, 2022
Application in European Union Seeking Approval of IMBRUVICA (ibrutinib) for the Treatment of Patients with Untreated Mantle Cell Lymphoma withdrawn December 19, 2022
U.S. FDA Breakthrough Therapy Designation Granted for Revumenib for the Treatment of Patients with R/R KMT2A- Rearranged (MLLr) Acute Leukemia December 12, 2022
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indication of Tecentriq® for the treatment of cisplatin-ineligible, PD-L1+ve adults with locally advanced or mUC to be withdrawn December 5, 2022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
