Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with R/R DLBCL July 27, 2023
Positive EU CHMP Opinion for KEYTRUDA + Trastuzumab + Chemo as 1L Treatment for HER2-Positive Advanced GEJ Adenocarcinoma Expressing PD-L1 (CPS ≥1) July 27, 2023
Positive CHMP Opinions for TALVEY (talquetamab) and TECVAYLI (teclistamab) for the Treatment of Patients with R/R Multiple Myeloma July 27, 2023
Positive CHMP Opinion to ORSERDU® (Elacestrant) for ER+, HER2-, ESR1-mutated Locally Advanced or Metastatic Breast Cancer patients July 22, 2023
FDA granted Fast Track Designation for REQORSA® Immunogene Therapy for patients with extensive-stage small cell lung cancer (ES-SCLC) July 19, 2023
Supplemental NDA submitted to FDA for BRUKINSA + obinutuzumab in R/R follicular lymphoma July 19, 2023
FDA clears FDA INDA for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer July 19, 2023
Registrational Pivotal Phase III Study of Olverembatinib for the First-Line Treatment of Patients with Ph+ ALL Approved by the CDE in China July 19, 2023
Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC provided; positive FDA Feedback Supports IOV-LUN-202 Trial Design for Accelerated Approval of TIL Therapy in Post-Anti-PD-1 Advanced NSCLC July 19, 2023
Paxalisib Receives Fast Track Designation From FDA For Treatment Of Solid Tumor Brain Mets Harboring PI3K Pathway Mutations In Combination With Radiation Therapy July 11, 2023
FDA Clears Investigational New Drug Application for CFT8919 Targeting EGFR L858R for Non-Small Cell Lung Cancer July 11, 2023
Design for Confirmatory Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer Announced July 11, 2023
The European Commission Grants Orphan Drug Designation to Temferon™ for Treatment of Glioma July 11, 2023
U.S. FDA grants Fast Track Designation to REQORSA® in Combination with Tecentriq® for the Treatment of Small Cell Lung Cancer July 5, 2023
Zenocutuzumab granted Breakthrough Therapy Designation by US FDA for the treatment of NRG1+ pancreatic cancer July 5, 2023
FDA OKays Proceeding with Phase 1/2 Trials of NEO212 for Primary Brain Tumors and for Brain Metastasis in Combination with Standard of Care Therapy July 5, 2023
GAVRETO® (pralsetinib) Supplemental NDA approval by China NMPA for first-line treatment of patients with locally advanced or metastatic RET fusion-positive NSCLC July 5, 2023
