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Novo Nordisk Plans Denecimib U.S. Launch In H1 2027 Amid FDA Review Extension
Source: Nasdaq
Healthcare & BiotechRegulation & LegislationCorporate Guidance & Outlook
Novo Nordisk said the FDA's review of its Biologics License Application for denecimig in haemophilia A remains ongoing, and the agency provided no new regulatory timeline. The lack of clarity delays visibility on a potential approval catalyst and creates near-term uncertainty for Novo Nordisk's haemophilia pipeline.
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