Rakuten Medical Japan Announces Marketing Approval of Akalux® IV Infusion 250mg and BioBlade® Laser System ...
(WorldNews Japan)

SAN MATEO, Calif., Sept. 25, 2020 /PRNewswire/ -- Rakuten Medical Inc. is proud to announce that its wholly owned subsidiary Rakuten Medical Japan K.K. has received marketing approval in Japan from the Ministry of Health, Labour and Welfare for Akalux® IV Infusion 250mg (cetuximab saratolacan sodium) to treat unresectable locally advanced or recurrent head and neck cancer. BioBlade® Laser System, the medical device used in the combination with Akalux, was also approved on September 2nd. This combination was developed under the Rakuten Medical Illuminox™ platform. Akalux received Sakigake Designation in April 2019, and application for approval under the Conditional Early Approval System was...