FDA Grants Fast Track Designation to CRB-701 for the Treatment of R/R Metastatic Cervical Cancer December 10, 2024
FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous NSCLC With EGFR Mutations December 10, 2024
FDA granted RMAT designation to acimtamig and AlloNK (AB101) for the treatment of R/R HL December 10, 2024
Outcomes of Type D meeting with FDA to obtain guidance on the design of a Ph 3 study of VCN-01 + chemo in metastatic pancreatic adenocarcinoma (PDAC) announced December 10, 2024
AdAPT-001 Receives FDA Fast Track Designation for Recurrent or Refractory Soft Tissue Sarcoma Treatment December 10, 2024
FDA Orphan Drug Designation for Azeliragon for the Treatment of Brain Metastasis From Breast Cancer December 10, 2024
Imfinzi granted Priority Review in the US for patients with muscle-invasive bladder cancer December 10, 2024
FDA Clears IND Application for Ph 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic CRC December 4, 2024
Results from End-of-Phase 2 Meeting with FDA for IMNN-001 Program in Advanced Ovarian Cancer Announced November 26, 2024
FDA Accepts Supplemental NDA for NUBEQA® (darolutamide) for the Treatment of Patients with Metastatic HSPC November 26, 2024
Breakthrough Therapy Designation for RP1 and RP1 BLA submitted to the FDA under the Accelerated Approval Pathway November 26, 2024
FDA Granted Orphan Drug Designation of LBL-024 for Treatment of Neuroendocrine Cancer November 26, 2024
NDA for Lisaftoclax Accepted and Recommended Priority Review Designation by CDE of China NMPA November 26, 2024
Blenrep combinations accepted for review by the FDA for the treatment of R/R multiple myeloma November 26, 2024
