In March, the US Food and Drug Administration (FDA) issued several notable regulatory decisions spanning immunology, dermatology, diabetes management, and obesity care. The following list details 5 key updates for primary care, including approval of deucravacitinib for psoriatic arthritis, a first-in-class oral IL-23 receptor–targeted peptide for plaque psoriasis, a higher-dose semaglutide formulation for obesity, a once-weekly basal insulin, and a next-generation automated insulin delivery system.

Several of the decisions reflect continued expansion of oral treatment options and evolving approaches to chronic inflammatory disease management. Others highlight incremental but potentially meaningful changes in how clinicians may approach long-term therapy selection, particularly in conditions where adherence, tolerability, and patient preference remain central considerations.

Additional updates focus on metabolic disease and diabetes care, where both pharmacologic and device-based innovations continue to reshape management strategies. Together, these actions underscore the pace of regulatory activity across high-prevalence conditions encountered in primary care and signal areas where practice patterns may continue to evolve.

US FDA Approves First and Only TYK2 Inhibitor for the Treatment of Psoriatic Arthritis

On February 27, 2026, Bristol Myers Squibb announced US FDA approval of deucravacitinib (Sotyktu) for the treatment of adults with active psoriatic arthritis. Based on results from the phase 3 POETYK PsA-1 (NCT04908202) and POETYK PsA-2 (NCT04908189) trials involving approximately 1400 patients, deucravacitinib demonstrated significantly higher ACR20 response rates vs placebo at week 16 (54.2% vs 34.1% and 39.4%), with sustained efficacy through week 52. The therapy also showed improvements in skin outcomes (PASI75 40.9% vs 15.4%) and quality-of-life measures. This approval introduces a new oral TYK2 inhibitor option targeting both joint and dermatologic manifestations of psoriatic disease.

FDA Approves Icotrokinra (Icotyde): First Oral IL-23 Receptor Antagonist for Moderate-to-Severe Plaque Psoriasis

On March 18, 2026, Johnson & Johnson announced US FDA approval of icotrokinra (Icotyde) for the treatment of moderate-to-severe plaque psoriasis in patients aged ≥12 years weighing ≥40 kg who are candidates for systemic therapy or phototherapy. Based on data from the phase 3 ICONIC program (≈2500 participants), icotrokinra achieved IGA 0/1 responses in 65% vs 8% with placebo and PASI 90 in 50% vs 4% at week 16, with further improvements through week 24. Head-to-head trials demonstrated superiority over deucravacitinib for skin clearance, with similar or lower adverse event rates and no new safety signals through 52 weeks. This approval introduces the first oral targeted peptide IL-23 receptor inhibitor, representing a new mechanistic class in systemic psoriasis treatment.

FDA Clears Smartphone-Controlled Insulin Pump for Children, Adults With Diabetes

On March 18, 2026, MiniMed announced US FDA clearance of the MiniMed Flex automated insulin delivery system for individuals aged ≥7 years with type 1 diabetes and adults with insulin-requiring type 2 diabetes. Based on real-world data demonstrating approximately 80% time in range (70–180 mg/dL) using its SmartGuard algorithm with Meal Detection technology, the system automates insulin delivery and correction in real time. The compact, smartphone-controlled pump is approximately half the size of the MiniMed 780G and features a screenless, app-based interface with a 300-unit reservoir and extended infusion set use up to 7 days. A limited rollout is expected in spring 2026, with broader US availability in summer 2026.

FDA Approves High-Dose Semaglutide 7.2 mg for Obesity

On March 19, 2026, Novo Nordisk announced US FDA approval of semaglutide 7.2 mg (Wegovy HD) for the treatment of obesity in adults requiring additional weight reduction after tolerating the 2.4-mg dose. Based on the STEP UP clinical trial program, the higher dose achieved a mean weight loss of 20.7% over 72 weeks, with approximately one-third of participants losing ≥25% of body weight. In a parallel phase 3 trial in individuals with obesity and type 2 diabetes, mean weight loss was 14.1%, with a safety profile consistent with prior semaglutide studies and no new safety signals. The therapy is expected to be available in the US in April 2026 as a single-dose pen formulation.

FDA Approves Once-Weekly Basal Insulin for Adults With Type 2 Diabetes

On March 26, 2026, Novo Nordisk announced US FDA approval of insulin icodec-abae (Awiqli) for the treatment of adults with type 2 diabetes as a once-weekly basal insulin adjunct to diet and exercise. Based on the phase 3a ONWARDS program (≈2680 participants), insulin icodec demonstrated effective HbA1c reduction comparable to daily basal insulin regimens, with a safety profile consistent with the class. The U-700 formulation is administered once weekly via a prefilled pen, reducing injection frequency from seven to one per week. The therapy is expected to be available in the US in the coming months.