mRNA-4157/V940 + KEYTRUDA® combo Granted Breakthrough Therapy Designation by the FDA for Adjuvant Treatment of Patients With High-Risk Melanoma Following Complete Resection February 28, 2023
FDA grants Fast Track designation for KIN-3248 for the treatment of patients with metastatic cholangiocarcinoma February 22, 2023
Regulatory update provided on the clinical development plan of Tedopi® in Ph 3 in monotherapy in advanced or mNSCLC after checkpoint inhibitor failure February 22, 2023
China NMPA Clears IND Application for Ph 1/2 Trial of FasTCAR-T GC012F for Treatment of R/R Multiple Myeloma February 22, 2023
FDA grants Orphan Drug Designation for the PRMT5 inhibitor JBI-778 for the treatment of Glioblastoma Multiforme (GBM) February 22, 2023
Refusal to File Letter issued from U.S. FDA for HyBryte™ New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma February 22, 2023
FDA Clears IND Application for Ph 1b/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of R/R Multiple Myeloma February 22, 2023
Orphan Drug Designation Granted to Adze-1.17-CD40L for the treatment of Malignant Glioma February 22, 2023
US FDA Advisory Committee votes in support of trials designed to evaluate Jemperli as a potential treatment for MMR-D/MSI-high locally advanced rectal cancer February 22, 2023
Fast Track Designation from the FDA for Tamibarotene for the Treatment of Higher-Risk Myelodysplastic Syndrome February 1, 2023
IND cleared for SC291, a Hypoimmune-modified, CD19-targeted Allogeneic CAR T Therapy for Patients with B-Cell Malignancies February 1, 2023
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
