FDA accepts Supplemental BLA and EMA Validates Application for Opdivo as an Adjuvant Treatment for Patients with Completely Resected Stage IIB or IIC Melanoma March 15, 2023
Update provided on US Regulatory Review of LYNPARZA + Abiraterone in metastatic CRPC patients March 15, 2023
Elranatamab Receives FDA and EMA Filing Acceptance with Submissions based on favorable MagnetisMM-3 trial results in patients with R/R multiple myeloma February 28, 2023
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
