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Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA

Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA

Fast Track designation granted for investigational TEV-53408, an anti-IL-15 antibody Designation underscores the potential of TEV-53408, currently undergoing a Phase 2a study for the treatment of celiac disease Candidate demonstrates Teva’s commitment to bringing important new treatment options to underserved patient populations TEL AVIV, Israel, May 27, 2025 (Korea Bizwire) – Teva Pharmaceutical Industries, Ltd. [...]

Invivoscribe Submits LeukoStrat CDx FLT3 Mutation Assay both in the US and Japan to Support Daiichi Sankyo Submissions for Quizartinib

Invivoscribe Submits LeukoStrat CDx FLT3 Mutation Assay both in the US and Japan to Support Daiichi Sankyo Submissions for Quizartinib

SAN DIEGO, Nov. 27 (Korea Bizwire) — In support of an ongoing partnership with Daiichi Sankyo, Invivoscribe is pleased to announce submissions of the LeukoStrat® CDx FLT3 Mutation Assay to both the US FDA and the Japan PMDA (Pharmaceuticals and Medical Devices Agency) as the companion diagnostic for quizartinib, which follows Daiichi Sankyo’s respective FDA [...]