FDA Clears IND Application for LTZ-232 to Treat Advanced Metastatic CRC and Other Solid Tumors July 15, 2026
HETRONIFLY (serplulimab) recommended by the NICE for routine use within the NHS in England and Wales July 7, 2026
Datroway recommended for approval in the EU by CHMP for patients with 1L metastatic TNBC who are not candidates for immunotherapy June 30, 2026
BfArM Approval to Initiate Ph 2/3 Trial of SIL204 in Locally Advanced Pancreatic Cancer June 30, 2026
CHMP recommendation advances TECVAYLI (teclistamab) plus daratumumab as a potential standard of care for RRMM June 30, 2026
UAE IND Approval obtained for NEO212 Following Successful Ph 1 Completion, Advancing Toward Global Ph 2 Development June 23, 2026
IND application for HLX3902 approved in China for treatment of metastatic CRPC and solid tumors June 23, 2026
Positive Pre-IND Feedback from Received US FDA for CLD-401; IND enabling studies to continue with IND submission targeted by end of 2026 June 23, 2026
FDA cleared CTA for LILRB4/CD3 targeting TCE bispecific antibody (6MW5311) for the treatment of AML, CMML, and Multiple Myeloma June 17, 2026
TCX-001 approved by SwissMedic for First-in-Human Ph 1 trial in patients with R/R AML and CLL June 17, 2026
FDA accepted supplemental BLA filing for adjuvant Tecentriq and Tecentriq Hybreza in combination with chemo in stage III dMMR or MSI-H colon cancer and granted Priority Review; PDUFA: 9 October 2026 June 17, 2026
FDA Clearance Received to Complete Enrollment in REGAIN Recurrent GBM Trial and Addition of Two US Clinical Sites June 17, 2026
Alignment with FDA obtained on 80 mg QD as RP3D and on the 2L+ patient population for the ENABLE-2 pivotal trial of ELVN-001 in CML patients June 17, 2026
