Astellas to Present New Long-Term Survival Data for Cancer Therapies at ASCO 2025
Astellas will showcase 16 abstracts at the 2025 ASCO Annual Meeting, including two oral presentations highlighting long-term survival data for its oncology portfolio.
Astellas Seeks First Japanese Approval for Geographic Atrophy Treatment with Avacincaptad Pegol
Astellas Pharma has submitted a New Drug Application to Japan's MHLW for avacincaptad pegol, potentially becoming the first approved treatment for geographic atrophy in Japan.
China NMPA Approves Padcev Plus Keytruda for Advanced Urothelial Cancer
China's NMPA has approved Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer (la/mUC).
China NMPA Approves Astellas' Zolbetuximab for Advanced Gastric and GEJ Adenocarcinoma
China's NMPA has approved zolbetuximab (VYLOYâ„¢) for first-line treatment of HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
FDA Issues Complete Response Letter for Astellas' IZERVAY and Accepts Aldeyra's NDA for Reproxalap
The FDA issued a Complete Response Letter for Astellas' IZERVAY (avacincaptad pegol) due to a statistical matter regarding proposed labeling language, unrelated to safety or efficacy.
FDA Issues Complete Response Letter for Astellas' Izervay sNDA
The FDA issued a Complete Response Letter (CRL) for Astellas' supplemental New Drug Application (sNDA) for Izervay on November 15.
FDA Approves First CLDN18.2-Targeting Antibody Vyloy (zolbetuximab) for Gastric Cancer
The FDA has approved Vyloy (zolbetuximab), a CLDN18.2-targeting monoclonal antibody, marking the first therapy of its kind approved in the U.S.
Enfortumab Vedotin Plus Pembrolizumab Approved in Japan for Urothelial Carcinoma
The Japanese Ministry of Health, Labour and Welfare approved enfortumab vedotin plus pembrolizumab for first-line treatment of radically unresectable urothelial carcinoma.