5 FDA Decisions for Primary Care to Know from May 2026

In May, the US Food and Drug Administration (FDA) issued several notable regulatory decisions spanning diabetes care, hypertension, infectious disease, kidney disease, and neuropsychiatric treatment. The following list highlights 5 key updates for primary care, including a pediatric expansion for an inhaled mealtime insulin, approval of a first-in-class hypertension therapy, and the first FDA-approved treatment for chronic hepatitis delta virus infection.

Several actions focused on chronic conditions commonly encountered or comanaged in primary care, where treatment burden, long-term adherence, and safety monitoring remain central to clinical decision-making. These updates include therapies that may offer new administration options, distinct mechanisms of action, or potential advances for patient populations with limited disease-specific treatment choices.

Other developments reflect ongoing regulatory movement in areas where evidence is still emerging, including kidney disease in type 1 diabetes and adjunctive treatment for bipolar depression. Together, the 5 decisions underscore the breadth of recent FDA activity and highlight therapeutic areas where primary care clinicians may need to follow evolving indications, monitoring considerations, and future trial data.

1. First Inhaled Mealtime Insulin for Children and Adolescents With Diabetes

On May 29, 2026, MannKind announced US FDA approval of insulin human inhalation powder (Afrezza) for use in children and adolescents aged ≥6 years with type 1 or type 2 diabetes. Based on findings from the phase 3 INHALE-1 trial (NCT04974528) and additional long-term safety and efficacy data, the approval expands Afrezza’s indication beyond adults and introduces a needle-free, ultra rapid-acting mealtime insulin option for pediatric patients. Afrezza is administered at the beginning of meals using a portable inhaler and must be used with basal insulin in patients with type 1 diabetes. The prescribing information includes a boxed warning for acute bronchospasm in patients with chronic lung disease, and lung function testing is recommended before and during treatment.

2. Baxdrostat Approved for Uncontrolled Hypertension on Background Therapy

On May 18, 2026, AstraZeneca announced US FDA approval of baxdrostat (BAXFENDY) for use in combination with other antihypertensive agents in adults whose blood pressure remains inadequately controlled. Based on the phase 3 BaxHTN trial, baxdrostat significantly reduced seated systolic blood pressure at week 12, with placebo-adjusted reductions of 9.8 mm Hg with the 2-mg dose and 8.7 mm Hg with the 1-mg dose. The approval introduces the first aldosterone synthase inhibitor for hypertension, offering a mechanistically distinct add-on option that suppresses aldosterone production. Key safety considerations include hyperkalemia and hyponatremia, with baseline and periodic electrolyte monitoring recommended.

3. FDA Grants Fast Track Status to Elunetirom for Bipolar Depression

On May 26, 2026, Autobahn Therapeutics announced US FDA Fast Track designation for elunetirom (ABX-002) for the adjunctive treatment of depressive episodes associated with bipolar I or bipolar II disorder in adults. Based on its potential to address unmet need in bipolar depression, the investigational once-daily oral small molecule prodrug is designed to penetrate the central nervous system and activate CNS thyroid hormone receptors while limiting peripheral thyroid hormone receptor effects. Elunetirom is currently being evaluated in the phase 2 AMPLIFY-BD trial (NCT06869187), with topline data expected in the second quarter of 2026. The designation does not establish safety or efficacy, but may allow more frequent FDA communication and potential eligibility for expedited review mechanisms.

4. Finerenone Gets FDA Priority Review for Type 1 Diabetes With Chronic Kidney Disease (CKD)

On May 21, 2026, Bayer announced US FDA acceptance and Priority Review of a supplemental New Drug Application for finerenone (Kerendia®) for use in adults with type 1 diabetes and CKD. Based on the phase 3 FINE-ONE trial, finerenone significantly reduced urine albumin-to-creatinine ratio compared with placebo over 6 months, with a least-squares mean change of 0.75 (95% CI, 0.65-0.87; P<.001). If approved, finerenone would become the first mineralocorticoid receptor antagonist indicated for adults with type 1 diabetes and CKD. Safety findings were generally consistent with prior finerenone experience, although hyperkalemia occurred more often with finerenone than placebo.

5. FDA Approves First Treatment for Chronic Hepatitis Delta Virus Infection

On May 22, 2026, Gilead Sciences announced US FDA accelerated approval of bulevirtide-gmod (Hepcludex®) for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. Based on the phase 3 MYR301 trial, 48% of participants receiving bulevirtide achieved a combined virologic and biochemical response at week 48 vs 2% with delayed treatment. The approval marks the first FDA-approved therapy for chronic HDV infection, a serious viral liver disease that occurs only in individuals with hepatitis B virus infection. The prescribing information includes a boxed warning for severe acute exacerbations of HDV and HBV infection after treatment discontinuation.