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
Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alpha in Non-Small Cell Lung Cancer May 31, 2023
Claudin 18.2 Antibody-Drug Conjugate ATG-022 Granted Orphan Drug Designations by the U.S. FDA for the Treatment of Gastric and Pancreatic Cancers May 31, 2023
Type II variation application to EMA submitted for a new indication for CARVYKTI in adult patients with relapsed and lenalidomide-refractory multiple myeloma May 31, 2023
Positive CHMP Opinion to Opdivo + Chemo as Neoadjuvant Treatment of Resectable NSCLC at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression May 31, 2023
NDA for Fruquintinib for Treatment of Previously Treated mCRC Granted Priority Review; PDUFA: Nov 2023 May 31, 2023
NMPA Breakthrough Designation for IBI351 (KRASG12C Inhibitor) as Monotherapy for Previously Treated Advanced Colorectal Carcinoma May 18, 2023
CHMP recommends EU approval of Roche’s fixed-duration Columvi (glofitamab) for people with R/R DLBCL May 10, 2023
