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
FDA accepts Supplemental NDA for Onivyde regimen in 1L metastatic pancreatic ductal adenocarcinoma June 21, 2023
FDA gives go-ahead to Proceed with STAR-LLD Lenalidomide Phase 1b Clinical Trial in Multiple Myeloma June 21, 2023
505(b)(2) NDA Approval granted from FDA for PEMRYDI RTU®, a Ready-to-Use Oncology Injectable June 21, 2023
6-Year OS Results Added to US Prescribing Information for ADCETRIS® (brentuximab vedotin) as 1L Treatment for Advanced Hodgkin Lymphoma June 21, 2023
Capivasertib in combination with Faslodex granted Priority Review in the US for patients with advanced HR-positive breast cancer June 21, 2023
Supplemental BLA accepted for priority review for Jemperli + chemo For The Treatment of dMMR/MSI-H Primary Advanced Or Recurrent Endometrial Cancer June 14, 2023
