The US FDA New Drug Approvals in March 2026 

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 Therapeutics’ Avlayah for Hunter syndrome (MPS II), Corcept Therapeutics’ Lifyorli for platinum-resistant ovarian cancer, and Novo Nordisk’s Awiqli for type 2 diabetes. 

• Overall, March 2026 reflected a sustained FDA focus on delivering clinically meaningful innovations, from chronic liver disease and inflammatory dermatology to rare pediatric conditions, advanced oncology, and next-generation diabetes management. 

1. GSK Reports the US FDA Approval of Lynavoy for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus 

                Company: GSK 

               Product: Lynavoy 

               Active Ingredient: Linerixibat 

               Disease: Primary Biliary Cholangitis with Cholestatic Pruritus 

               Date: Mar 17, 2026   

               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 rapid (at wk. 2) & sustained (over 24wks.) improvement in cholestatic pruritus along with reduced itch-related sleep interference 

2. Johnson & Johnson Reports the US FDA Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO) 

                Company: Johnson & Johnson 

               Product: Icotyde 

               Active Ingredient: Icotrokinra 

               Disease: Plaque Psoriasis   

               Date: Mar 17, 2026   

               Shots: 

• The US FDA has approved Icotyde for the treatment of pts (≥12yrs., ≥40kg) with mod. to sev. plaque PsO who are candidates for systemic therapy or phototherapy 

• Approval was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where Icotyde met all 1EP across all 4 trials (n=2,500). In the head-to-head studies, ~70% pts achieved IGA 0/1 & 55% reached PASI 90 at Wk. 16 

• Icotyde (JNJ-2113) is also being assessed in ICONIC-PsA 1 & 2 (vs PBO) for active psoriatic arthritis, ICONIC-UC for mod. to sev. active ulcerative colitis & ICONIC-CD for mod. to sev. active Crohn’s disease 

3. The US FDA Grants Accelerated Approval Denali Therapeutics’ Avlayah (Tividenofusp alfa-eknm) for Hunter Syndrome (MPS II) 

                Company: Denali Therapeutics 

               Product: Avlayah 

               Active Ingredient: Tividenofusp alfa-eknm 

               Disease: Hunter Syndrome 

               Date: Mar 24, 2026   

               Shots: 

• FDA has granted accelerated approval to Avlayah, an enzyme replacement therapy (ERT), for the treatment of presymptomatic or symptomatic MPS II pediatric pts (≥5kg), along with a RPD PRV to Denali; US availability is expected shortly 

• Approval was based on the P-I/II trial of Avlayah (QW) in 47 pts, incl. ERT-naïve (n=15) & previously treated (n=32), with CSF HS reduction as a surrogate endpoint, showing a 91% decrease & 93% pts reaching normal levels at Wk. 24; data were published in The NEJM 

• Avlayah is being evaluated in the ongoing global P-II/III (COMPASS) trial in pts, incl. young adults living with MPS II, to generate confirmatory evidence & support global regulatory filings 

4. Corcept Therapeutics Reports the US FDA Approval of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer 

                Company: Corcept Therapeutics   

               Product: Lifyorli 

               Active Ingredient: Relacorilant 

               Disease: Platinum-Resistant Ovarian Cancer 

               Date: Mar 25, 2026  

               Shots: 

• The US FDA has approved Lifyorli (relacorilant) + nab-paclitaxel for the treatment of adults with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic therapy, ≥1 of which included Avastin 

• Approval was supported by P-III (ROSELLA) assessing Lifyorli + nab-paclitaxel vs nab-paclitaxel alone in above mentioned pts (n-=381) with no need for biomarker selection   

• Trial met its dual 1EP of improved PFS & OS, showing a 35% reduction in death risk (mOS: 16 vs 11.9mos.) & a 30% reduction in the risk of disease progression as assessed by BICR; data was published in The Lancet 

5. Novo Nordisk’s Awiqli Receives the US FDA Approval for Type 2 Diabetes 

                Company: Novo Nordisk 

               Product: Awiqli   

               Active Ingredient: Insulin Icodec-abae 

               Disease: Type 2 Diabetes 

               Date: Mar 26, 2026  

               Shots: 

• The US FDA approved Awiqli (insulin icodec-abae; 700 units/mL) to improve glycaemic control in adults with type 2 diabetes as an adjunct to diet & exercise, with Novo planning a US launch in the FlexTouch device in H2’26 

• Approval was based on the P-IIIa (ONWARDS) program assessing Awiqli (QW) vs basal insulin (QD) in four treat-to-target trials (~2,680 adults with uncontrolled T2D), used with mealtime insulin or oral anti-diabetic agents &/or GLP-1 receptor agonists 

• The trials showed HbA1c reduction, with safety profile of Awiqli consistent with the daily basal insulin class 

Related Post: Insights+: The US FDA New Drug Approvals in February 2025