Regulatory Fast-Tracks Fuel Innovation: FDA and EMA Prioritize NK Cell Therapies, Accelerating Approval Pathways for Unmet Needs
Regulatory agencies are stepping up to accelerate innovation in the natural killer (NK) cell therapeutics market, recognizing their potential to address unmet medical needs in oncology and beyond. The FDA’s Breakthrough Therapy designation and EMA’s “Advanced Therapy Medicinal Product” (ATMP) classification have significantly shortened approval timelines for NK...
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