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April 06, 2026
Article
A look at 13 key FDA approvals from Q1 2026, highlighting advances in rare disease, pediatrics, novel therapies, and patient-centered innovation.
April 01, 2026
The Agency approved Lilly’s orforglipron (Foundayo) for adults with obesity or overweight. It can be taken any time of the day without restrictions on food and water intake.
FDA approvals broaden ALYFTREK and TRIKAFTA eligibility to nearly 95% of US cystic fibrosis patients using a functional, mechanism-based variant criterion.
March 27, 2026
The indication makes insulin icodec the first new class of basal insulin to reach US patients in more than 2 decades.
March 23, 2026
Podcast
This episode features discussion around 3 recent announcements from Novo Nordisk, Eli Lilly, and Structure Therapeutics.
March 20, 2026
FDA clears setmelanotide for acquired hypothalamic obesity for ages 4 years and older, delivering 15.8% BMI drop in TRANSCEND.
March 19, 2026
The IBAT inhibitor’s approval, the first for this indication, was based on data from the GLISTEN trial showing reductions in cholestatic pruritus and itch-related sleep interference.
The approval is based on results from the STEP UP trial program showing substantial weight loss in adults with obesity.
March 18, 2026
The MiniMed Flex is a discreet, smartphone-controlled insulin pump that is roughly the size of 2 stacked insulin vials.
FDA clears once-daily icotrokinra for moderate-to-severe plaque psoriasis in adults and teens.
