Favorable IDMC Recommendation to Continue Ph 3 PANOVA-3 Clinical Trial of Tumor Treating Fields Therapy in Pancreatic Cancer July 27, 2023
EMA provides negative Review in the European Union of KRAZATI (adagrasib) for the Treatment of Advanced NSCLC with a KRAS G12C Mutation July 27, 2023
FDA accepts Filing of NDA for Rivoceranib + Camrelizumab as a First-line Treatment for Unresectable HCC July 27, 2023
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
