AbbVie Submits Regulatory Application to FDA for Subcutaneous SKYRIZI
On April 27, 2026, AbbVie announced that it has submitted a regulatory application to the FDA seeking approval for SKYRIZI (risankizumab-rzaa) for subcutaneous induction for the treatment of adult patients with moderately to severely active Crohn’s disease. AbbVie states that its application is supported by positive data from the Phase 3 AFFIRM study, which evaluated the efficacy and safety of SKYRIZI as a subcutaneous induction treatment in adult patients with moderately to severely active Crohn’s disease, including both those with and without prior advanced therapy failure.
AbbVie Selects North Carolina for New $1.4 Billion Manufacturing Campus
On April 22, 2026, AbbVie announced plans to invest $1.4 billion in a new 185-acre pharmaceutical manufacturing campus in Durham, North Carolina. The state-of-the-art facility will integrate advanced manufacturing and laboratory technologies with artificial intelligence to support the production across AbbVie’s immunology, neuroscience, and oncology medicines. This marks AbbVie’s first major investment in North Carolina and “represents a significant milestone for AbbVie as our largest capital investment to date and an important expansion of our manufacturing footprint into a new region of the United States,” said Robert A. Michael, chairman and chief executive officer, AbbVie. Construction is expected to begin this year, with completion targeted for the end of 2028.
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