Japan has granted marketing approval to Oncolys Biopharma Inc.’s oncolytic adenovirus product, Telomelysin (suratadenoturev, OBP-301), for treating esophageal cancer in patients who are not eligible for curative resection or chemoradiotherapy. The approval marks the first oncolytic adenovirus product approved for esophageal cancer.
The U.S. FDA approved Shionogi & Co. Ltd.’s Xocova (ensitrelvir) as the first oral post-exposure prophylactic option in the U.S. to prevent COVID-19, with the decision coming ahead of a PDUFA target date of June 16.
Japan has approved the world’s first therapies derived from induced pluripotent stem cells (iPSCs), marking a major milestone for regenerative medicine and, potentially, a turning point in treating Parkinson’s disease.