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
FDA Accepts Application for KEYTRUDA Plus Chemotherapy as Treatment for Advanced or Unresectable Biliary Tract Cancer June 14, 2023
NDA submitted to Japan’s MHLW for zolbetuximab in 1L CLDN18.2-positive HER2-neg gastric or gastroesophageal junction (mGEJ) adenocarcinoma patients June 14, 2023
Supplemental BLA submitted to FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with R/R Multiple Myeloma June 14, 2023
FDA Accepts for Priority Review Repotrectinib’s Application for the Treatment of Patients with Locally Advanced or Metastatic ROS1-Positive NSCLC June 6, 2023
