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
POINT Biopharma Announce FDA Grants Fast Track Designation for 177Lu-PNT2002 for the Treatment of metastatic CRPC May 10, 2023
FDA grants Orphan Drug Designation for INB-400/410 for the Treatment of Newly Diagnosed Glioblastoma May 10, 2023
Type A Meeting Request submitted to FDA to Review Proposed Study Design for a Second Ph 3 Study Evaluating HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma May 10, 2023
Positive Interim Ph 2 Data for Darovasertib + Crizotinib Combination and Successful FDA Type C Meeting on Registrational Trial Design for Accelerated Approval in 1L Metastatic Uveal Melanoma announced May 10, 2023
EMA Validates MAA for Jemperli (dostarlimab) + Chemo for the Treatment of dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer May 10, 2023
