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Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective - The AAPS Journal SpringerLink remove preview Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective - The AAPS Journal On February 24, 2021, the U.S. Food and Drug Administration (FDA) approved an efficacy supplement for HUMIRA® (adalimumab) injection to expand the indication of treatment of moderately to severely active ulcerative colitis (UC) to include pediatric patients 5 years of age and older. View this on SpringerLink >

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Ho-Leung Fung Ph.D., FAAPS
Editor-in-Chief
University at Buffalo
Buffalo NY
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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