FDA approvals - March 2026
New options emerged in PBC-associated itch, plaque psoriasis, neurologic Hunter syndrome, and platinum-resistant ovarian cancer.
Novo Nordisk's Awiqli delivers the first once-weekly basal insulin for type 2 diabetes
The first once-weekly basal insulin reaches US patients, cutting injection burden from 365 to 52 per year and demonstrating superior glycaemic control in the ONWARDS program
FDA approves Rocket's Kresladi as the first gene therapy for severe leukocyte adhesion deficiency-I
The first gene therapy for severe LAD-I achieves 100% HSCT-free survival with sustained CD18 expression through 42 months in paediatric patients lacking a matched donor
Denali’s AVLAYAH wins FDA accelerated approval in Hunter syndrome
The accelerated approval in Hunter syndrome was supported by Phase 1/2 biomarker data and adds a Priority Review Voucher alongside Denali’s first approved blood-brain barrier-penetrant biologic.
FDA Clears Corcept’s Relacorilant Plus Nab-Paclitaxel in Platinum-Resistant Ovarian Cancer
Corcept’s FDA approval establishes relacorilant as the first FDA-approved selective glucocorticoid receptor antagonist
Johnson & Johnson’s ICOTYDE brings a new oral IL-23 option to plaque psoriasis
On March 17, 2026, the FDA approved Johnson & Johnson’s ICOTYDE (icotrokinra) for adults and pediatric patients 12 years and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ICOTYDE is a once-daily oral IL-23 receptor antagonist, and Johnson
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
FDA greenlights Ascendis’ once-weekly YUVIWEL to boost growth in children with achondroplasia
On February 27, 2026, the FDA approved Ascendis Pharma’s YUVIWEL (navepegritide) (ASND, Nasdaq, Close: $233.50 - as of Feb. 27, 2026) to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. Navepegritide is a once-weekly subcutaneous C-type natriuretic peptide prodrug.
Immedica Pharma’s Loargys adds an enzyme-replacement entrant for ultra-rare ARG1-D–related hyperargininemia
On February 23, 2026, the FDA approved Loargys (pegzilarginase-nbln) from Immedica Pharma for hyperargininemia in adults and pediatric patients 2 years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction. ARG1-D affects an estimated 250 people in the U.S.A. Immedica Pharma’s CEO, Anders Edvell,
FDA approves Vanda’s Bysanti for schizophrenia and bipolar I manic or mixed episodes
On February 20, 2026, the FDA approved Bysanti (milsaperidone) from Vanda Pharmaceuticals (VNDA, Nasdaq) for schizophrenia and for manic or mixed episodes associated with bipolar I disorder in adults. Vanda describes Bysanti as a new chemical entity atypical antipsychotic that is bioequivalent to iloperidone across the therapeutic dosing spectrum, enabling
Acrotech Biopharma brings a new topical PDE4 option - Adquey - into a crowded eczema market.
On February 12, 2026, the FDA approved Adquey (difamilast 1%) ointment from Acrotech Biopharma for the topical treatment of mild to moderate atopic dermatitis in adults and pediatric patients aged 2 years and older. The commercial question centers on where difamilast can earn durable share against entrenched topicals. Mechanistically, difamilast
FDA approvals - January 2026
Copper replacement formalizes care for a fatal pediatric metabolic disorder.
FDA approvals - December 2025
The winter batch of FDA approvals featured therapies that compress intervention into fewer doses, fewer visits, and fewer points of failure.
FDA Approvals - November 2025
Mitochondrial disease and mutant leukemias signal where specialty pharma is placing its biggest bets.
