The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need
The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck
The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis
Otsuka will pay $700 million to Transcend shareholders at closing, with an additional $525 million in contingent payments tied to future sales milestones
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival
Iberdomide has the potential to be the first approved CELMoD agent
HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
Sofetabart mipitecan is a novel folate receptor alpha (FR?) antibody-drug conjugate (ADC) leveraging proprietary linker technology and an exatecan payload to target tumor cells
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
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