5 FDA Decisions for Primary Care to Know from February 2026

In February, the US Food and Drug Administration (FDA) issued several notable regulatory decisions over the month spanning obesity treatment devices, endocrine therapies, allergy and immunology, sexual health, and women’s health. The following list details 5 key updates for primary care, including a premarket approval for a swallowable device intended for weight management in adults with obesity, the approval of dupilumab for allergic fungal rhinosinusitis in adults and children aged 6 years and older with a history of sinonasal surgery, labeling revisions removing certain boxed warning risk statements from several menopausal hormone therapy labels, and more.

FDA Approves First “Smart Capsule” for Obesity

On February 23, 2026, Allurion announced US FDA premarket approval (PMA) for the Allurion Gastric Balloon System for weight management in adults with obesity (BMI 30–40 kg/m²). Based on findings from the AUDACITY pivotal randomized controlled trial of 550 participants, patients treated with the balloon plus behavioral support achieved 14% total body weight loss (TBWL), with >20% TBWL observed with sequential therapy or when combined with low-dose GLP-1 therapy. The device is a swallowable, procedure-free intragastric balloon that remains in the stomach for approximately 4 months before naturally deflating and passing, eliminating the need for endoscopic placement or removal. The trial reported a 3.1% serious adverse event rate, the lowest reported in an FDA pivotal trial for a liquid-filled intragastric balloon system.

Dupilumab Approved by FDA as First Targeted Therapy for Allergic Fungal Rhinosinusitis

On February 28, 2026, Sanofi and Regeneron announced US FDA approval of dupilumab (Dupixent) for the treatment of allergic fungal rhinosinusitis in adults and pediatric patients aged ≥6 years with a history of sinonasal surgery. Based on results from the phase 3 LIBERTY-AFRS-AIMS trial (NCT04684524), dupilumab produced a 50% reduction in sinus opacification vs 10% with placebo at week 52 (P < .0001) and significantly improved nasal congestion and nasal polyp size. The therapy also reduced the risk of systemic corticosteroid use and/or need for surgery by 92% over 52 weeks compared with placebo. This approval represents the first FDA-approved therapy specifically indicated for allergic fungal rhinosinusitis.

FDA Approves Desmopressin Acetate Oral Solution for Central Diabetes Insipidus

On February 26, 2026, Eton Pharmaceuticals announced US FDA approval of desmopressin acetate oral solution (DESMODA) for antidiuretic replacement therapy in patients with central diabetes insipidus (arginine vasopressin deficiency). Based on the need for precise dose titration in a rare disorder affecting approximately 13 000 individuals in the US, the product is the first FDA-approved oral liquid formulation of desmopressin for this indication. The 0.05 mg/mL ready-to-use solution is designed to facilitate individualized dosing across adult and pediatric populations without the need for tablet splitting, refrigeration, or mixing. The prescribing information includes a boxed warning for hyponatremia, with recommendations for fluid restriction and monitoring of serum sodium during treatment.

FDA Removes Boxed Warnings on Cardiovascular, Cancer, and Dementia Risks From Select Menopausal Hormone Therapy Labels

On February 26, 2026, the FDA announced labeling updates removing boxed warning risk statements for cardiovascular disease, breast cancer, and probable dementia from six menopausal hormone therapy (MHT) products used for menopause-related symptoms and bone loss prevention. Based on a comprehensive FDA review of the scientific literature initiated in November 2025, the changes apply across several hormone therapy categories, including systemic estrogen–progestogen combinations, estrogen-only therapies, progestogen therapy used with systemic estrogen, and topical vaginal estrogen. The revisions represent the first approvals among labeling updates submitted by 29 drug manufacturers at the FDA’s request. The agency stated the changes are intended to provide clearer, evidence-based risk information to support shared decision-making between clinicians and patients.

First Oral Film Treatment for Erectile Dysfunction in Men Gains FDA Approval

On February 27, 2026, IBSA USA announced US FDA approval of sildenafil oral film (VYBRIQUE) for the treatment of erectile dysfunction in men aged ≥18 years. Based on results from a phase 3 randomized, double-blind, placebo-controlled trial (NCT05490680) involving 475 participants, the therapy demonstrated significant improvements in sexual function compared with placebo over 12 weeks. The single-dose oral film dissolves on the tongue without water and is designed for administration 30 minutes to 4 hours before sexual activity. The product is expected to become commercially available in the US in March 2026.