Shots:
Approval momentum accelerated in late March 2026, with the US FDA clearing five new therapies across hepatology, dermatology, rare genetic disorders, oncology, and endocrinology; highlighting both therapeutic breadth and meaningful clinical impact.
Five notable therapies crossed the regulatory finish line: GSK’s Lynavoy for cholestatic pruritus in primary biliary cholangitis, Johnson & Johnson’s Icotyde for moderate-to-severe plaque psoriasis, Denali…
Shots:
The US FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in PBC pts; regulatory reviews in the EU, UK, Canada & China are ongoing
Approval was supported by P-III (GLISTEN) trial assessing Lynavoy (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus
Trial met its 1EP & key 2EPs showing…

