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Simulations Plus Positioned to Capitalize on FDA’s Streamlined Nonclinical Safety Guidance with Advanced Mechanistic and Model-Informed Solutions
RESEARCH TRIANGLE PARK, N.C., December 09, 2025--Simulations Plus, Inc. (Nasdaq: SLP) ("Simulations Plus" or the "Company"), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today responded to the U.S. Food and Drug Administration’s draft guidance on streamlined nonclinical safety studies for monospecific monoclonal antibodies. The guidance encourages reduced reliance on animal studies and elevates mechanistic understanding, pharmacokineti
About this update from Simulations Plus, Inc.
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