FDA Orphan Drug Designation for FORE8394 for the Treatment of Primary Brain and CNS Malignancies March 31, 2023
QINLOCK® Included in NCCN Guidelines® for the Treatment of Second-Line GIST Patients and FDA Grants Breakthrough Therapy Designation for QINLOCK in Second-Line GIST Patients with Mutations in KIT Exon 11 and 17/18 March 31, 2023
FDA Advisory Committee Votes In Favour of the Clinical Benefit of Polivy Combination For People With 1L DLBCL March 15, 2023
FDA Orphan Drug Designation Granted to Batiraxcept for the Treatment of Pancreatic Cancer March 15, 2023
FDA Clearance of IND Application for Phase 1/2 Clinical Trial (Starlight-1) of EB103, a CD19-Targeted ARTEMIS® T Cell Therapy, to Patients with B-Cell Lymphomas March 15, 2023
Libtayo® (Cemiplimab) + Chemotherapy combo Receives Positive CHMP Opinion For The Treatment Of Advanced PD-L1 Positive NSCLC March 15, 2023
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
