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
FDA grants Fast Track Designation for LAG-3 Therapeutic Eftilagimod Alpha for 1L NSCLC October 12, 2022
FDA grants Fast Track Designation for Sapanisertib in NRF2-mutated Squamous Lung Cancer October 12, 2022
Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial of PDS0101 in Combination With KEYTRUDA® October 12, 2022
