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Anis Fahandej-Sadi

Anis Fahandej-Sadi

Head Editor, TLDR Biotech

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FDA approvals - March 2026

FDA approvals - March 2026

New options emerged in PBC-associated itch, plaque psoriasis, neurologic Hunter syndrome, and platinum-resistant ovarian cancer.

FDA approves Alfasigma’s Lynavoy for primary biliary cholangitis

FDA approves Alfasigma’s Lynavoy for primary biliary cholangitis

On March 17, 2026, the US FDA approved Lynavoy (linerixibat) for cholestatic pruritus associated with primary biliary cholangitis.  The approval came days after GSK and Alfasigma announced a March 9 licensing agreement under which Alfasigma acquired exclusive worldwide rights to develop, manufacture, and commercialize linerixibat. Under the agreement, GSK receives