FDA Clears IND Application for Ph 1/2a Clinical Trial of LB101, First LockBody® Candidate, for Solid Tumors February 1, 2023
Positive End of Phase II Meeting with the FDA for Bria-IMT(TM) Combination in Advanced Metastatic Breast Cancer announced February 1, 2023
FDA clears IND for Novel Bispecific CAR IMPT-314 to Treat Aggressive B-cell Lymphoma February 1, 2023
Fast Track Designation Granted by the FDA to CFI-402257 for the Treatment of ER+/HER2- Breast Cancer January 17, 2023
IND approved for MUC1*-CAR-1XX with Increased Persistence and Ability to Kill Low Antigen Expressing Cells for Treatment of Solid Tumor Cancers January 17, 2023
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Union Seeking Approval of IMBRUVICA (ibrutinib) for the Treatment of Patients with Untreated Mantle Cell Lymphoma withdrawn December 19, 2022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
