Jemperli (dostarlimab-gxly) receives US FDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer December 18, 2024
Positive EU CHMP Opinion for WELIREG® (belzutifan) as Treatment for Adult Patients With Certain Types of VHL Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced RCC December 18, 2024
NDA for Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma to be submitted Before Year-End December 18, 2024
Jemperli (dostarlimab) + chemo receives positive CHMP opinion to expand approval to all adult patients with primary advanced or recurrent endometrial cancer December 18, 2024
FDA Clearance received to Administer AIV001 in Facial Skin by Intradermal Injection for Superficial and Nodular Superficial Basal Cell Carcinoma (sBCC and nBCC) December 18, 2024
FDA accepts IND application for initiation of a Ph 1 clinical trial to evaluate LNCB74 in multiple cancers December 18, 2024
Orphan Drug Designation from FDA for PLT012 in Treatment of Liver and Intrahepatic Bile Duct Cancer December 17, 2024
Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated NSCLC December 10, 2024
Blenrep (belantamab mafodotin) combination accepted for priority review in China in R/R multiple myeloma December 10, 2024
Regulatory Update Related to Supplemental NDA for Cabozantinib (CABOMETYX®) for the Treatment of Patients with Previously Treated Advanced NETs provided December 10, 2024
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
