PMDA Archives | Be Korea-savvy

Invivoscribe Submits the LeukoStrat CDx FLT3 Mutation Assay to Support Daiichi Sankyo Submission for Quizartinib in Japan

SAN DIEGO, Nov. 19 (Korea Bizwire) — In support of an ongoing partnership with Daiichi Sankyo, Invivoscribe is pleased to announce submission of the LeukoStrat® CDx FLT3 Mutation Assay to the PMDA (Pharmaceuticals and Medical Devices Agency) as the companion diagnostic for quizartinib, which follows Daiichi Sankyo’s PMDA application for quizartinib in Japan. Invivoscribe developed [...]

Invivoscribe® Receives Approval in Japan for its LeukoStrat® CDx FLT3 Mutation Assay to Assess Acute Myeloid Leukemia (AML) Patients Eligible for Treatment with Xospata® (gilteritinib fumarate)

SAN DIEGO, Sept. 27 (Korea Bizwire) — Invivoscribe® Inc., a global company providing biomarker and clonality test solutions for the fields of oncology and personalized molecular medicine® today announces Pharmaceuticals and Medical Devices Agency (PMDA) approval of the LeukoStrat CDx FLT3 Mutation Assay companion diagnostic. As the first company to receive both FDA and PMDA [...]