SYS6010 granted breakthrough therapy designation by NMPA in China for patients with actionable genomic alteration-negative non-squamous NSCLC September 22, 2026
Positive EU CHMP Opinion for KEYTRUDA + Padcev as Perioperative Treatment for Adults With Resectable MIBC September 22, 2026
Enhertu recommended for approval in the EU by CHMP as adjuvant treatment for patients with residual disease after neoadjuvant treatment for HER2-positive early breast cancer September 22, 2026
FDA clears new IND for GTB-5550 in multiple myeloma (MM) under an investigator sponsored trial (IST) protocol September 22, 2026
US FDA Breakthrough Therapy Designation for RASONQUE™ (daraxonrasib) + Chemo for 1L Metastatic Pancreatic Cancer September 22, 2026
FDA approves supplemental NDA for IBTROZI® (taletrectinib) for the treatment of locally advanced or metastatic ROS1+ NSCLC September 22, 2026
End-of-Phase 1 Meeting with FDA and Receipt of Fast Track Designation for LYT-200 in R/R High-Risk MDS Announced September 22, 2026
KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Approved in Japan for SubQ Administration for All KEYTRUDA Indications Approved in Japan September 22, 2026
FDA approves BEXLUTRY lutetium Lu 177 dotatate injection for adults with SSTR-positive GEP-NETs September 22, 2026
