asciminib (Scemblix)
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Certara Simcyp® Simulator Results Replace Ten Human Trials for Chronic Myeloid Leukemia (CML) Therapy asciminib
Globenewswire· 2026-03-03 13:00
Biosimulation results highlight how model-informed approaches for drug development and regulatory decision- making save time and money. RADNOR, Pa., March 03, 2026 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced its Simcyp Simulator enabled physiologically-based pharmacokinetic (PBPK) modeling predictions accepted by the U.S. FDA in lieu of clinical studies to support the new drug application (NDA) for asciminib (Scemblix). PBPK modeling ...