FDA News Recap: June 2025

Welcome back to our recap of this month's news and updates from the US Food and Drug Administration (FDA)!

June 2025 maintained robust regulatory activity, with the FDA addressing important therapeutic areas including rare diseases, infectious diseases, and chronic conditions. Approvals ranged from innovative long-acting prophylactics for hereditary angioedema to novel combination therapies for hypertension, underscoring ongoing advances in targeted treatments and patient-centered convenience. Meanwhile, regulatory updates also reflected challenges in manufacturing compliance that may impact emerging therapies in nephrology. Here’s a concise overview of the key FDA decisions and updates from June 2025.

Want to hear from the experts? Look for our Related Content links underneath blurbs for insight into how this decision might influence practice moving forward.

FDA News Month in Review: June 2025

FDA Approves Clesrovimab RSV Immunization for Newborns and Infants

On June 9, 2025, Merck announced FDA approval of clesrovimab (Enflonsia) for preventing RSV lower respiratory tract disease in neonates and infants entering their first RSV season. Based on data from the pivotal Phase 2b/3 CLEVER trial, clesrovimab reduced RSV-associated medically attended lower respiratory infections by 60.5% and hospitalizations by 84.3% through 5 months compared to placebo. Enflonsia is the first RSV preventive option given at a fixed 105 mg dose regardless of infant weight, providing direct and durable protection across a typical RSV season. Merck plans to launch Enflonsia in the U.S. ahead of the upcoming RSV season to address this leading cause of infant hospitalization.

Related Content: RX Review: RSV Prevention Strategies and the Changing Epidemiologic Landscape

FDA Approves Triple Combination Drug GMRx2 (WIDAPLIK) for Hypertension Treatment

On June 9, 2025, George Medicines announced FDA approval of GMRx2 (WIDAPLIK), a novel triple-combination pill of telmisartan, amlodipine, and indapamide for hypertension in adults. Based on data from two phase 3 trials and the VERONICA study, GMRx2 demonstrated superior blood pressure control and good tolerability versus placebo, dual therapies, and standard of care. The product, expected to launch in the US in Q4 2025, is the only FDA-approved triple combination for initial therapy in patients likely to require multiple antihypertensives.

FDA Approves Glecaprevir/Pibrentasvir (Mavyret) Label Expansion for Acute HCV

On June 11, 2025, AbbVie announced FDA approval of a label expansion for glecaprevir/pibrentasvir (Mavyret) to treat adults and pediatric patients ≥3 years with acute or chronic hepatitis C virus infection without or with compensated cirrhosis. Based on data from the phase 3 M20-350 study, Mavyret is now the first and only direct-acting antiviral approved for an 8-week treatment of acute HCV, achieving a 96% cure rate. This pan-genotypic, once-daily oral therapy continues to offer a high barrier to resistance and favorable safety, supporting efforts to expand curative treatment and advance HCV elimination goals.

FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation

On June 12, 2025, Amneal Pharmaceuticals announced FDA approval of prednisolone acetate ophthalmic suspension USP 1% for treating steroid-responsive ocular inflammation. Based on clinical trial data, the topical suspension is self-administered 2-4 times daily, with the potential for increased dosing in the first 24 hours, and carries risks including elevated intraocular pressure and rare optic nerve damage. Amneal plans to launch the product in Q3 2025, expanding its Affordable Medicines portfolio with this complex ophthalmic therapy.

FDA Approves Factor XIIa-Targeting Garadacimab-gxii (ANDEMBRY) for HAE Attacks

On June 16, 2025, CSL announced FDA approval of garadacimab-gxii (ANDEMBRY) for prophylactic prevention of hereditary angioedema (HAE) attacks in patients aged 12 years and older. Based on the phase 3 VANGUARD trial, garadacimab-gxii demonstrated a ≥99% median reduction in HAE attacks versus placebo, with 62% of treated patients remaining attack-free during treatment. Administered monthly via a quick, subcutaneous autoinjector, ANDEMBRY is the first HAE therapy targeting factor XIIa and offers a convenient once-monthly dosing option.

FDA Approves Lenacapavir, First Twice-Yearly HIV Prevention Option

On June 18, 2025, Gilead announced FDA approval of lenacapavir (Yeztugo) as a twice-yearly injectable pre-exposure prophylaxis (PrEP) for preventing sexually acquired HIV in adults and adolescents weighing at least 35 kg. Based on phase 3 PURPOSE 1 and PURPOSE 2 trials, lenacapavir demonstrated superior efficacy with zero HIV infections in cisgender women during the study and significantly fewer infections in men and gender-diverse individuals compared to daily oral PrEP. This novel dosing regimen offers a transformative option to improve adherence and reduce stigma associated with more frequent PrEP dosing.

FDA Approves Dupilumab (Dupixent) for Bullous Pemphigoid in Adult Patients

On June 20, 2025, Sanofi and Regeneron announced FDA approval of dupilumab (Dupixent) for the treatment of adult patients with bullous pemphigoid, marking its eighth indication. This approval was based on positive results from the ADEPT trial, where dupilumab demonstrated sustained disease remission and significant itch reduction compared to placebo. As the first targeted therapy for this type 2 inflammation-driven autoimmune skin disease, dupilumab offers a novel option that may reduce reliance on systemic corticosteroids and improve quality of life for affected patients.

FDA Approves Nitisinone (HARLIKU) for Treatment of Alkaptonuria

On June 19, 2025, Cycle Pharmaceuticals announced FDA approval of nitisinone (HARLIKU) for reducing urine homogentisic acid in adults with alkaptonuria (AKU), making it the first and only treatment approved for this rare genetic disorder. Based on a post-hoc analysis of a 2009 trial, nitisinone demonstrated improvements in patient-reported outcomes and physical function over three years, supporting its efficacy despite the original trial missing its primary endpoint. HARLIKU’s approval offers a long-awaited option to address the significant disease burden, including joint damage and decreased mobility, in AKU patients.

FDA Approves Belimumab (Benlysta) Autoinjector for Pediatric Lupus Nephritis

On June 24, 2025, GlaxoSmithKline announced FDA approval of a 200 mg/mL belimumab (Benlysta) autoinjector for subcutaneous use in patients aged 5 years and older with active lupus nephritis receiving standard therapy. Based on prior data supporting belimumab’s efficacy in systemic lupus erythematosus and lupus nephritis, this first-of-its-kind at-home administration option aims to reduce clinic visits and improve treatment flexibility for pediatric patients and caregivers. This approval marks the first biologic approved for both pediatric lupus and lupus nephritis, offering an important new tool for managing these severe autoimmune conditions.

FDA Issues CRL to Oxylanthanum Carbonate for Hyperphosphatemia in CKD, Dialysis

On June 30, 2025, Unicycive Therapeutics announced that the FDA issued a Complete Response Letter for its New Drug Application for oxylanthanum carbonate, a treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis. The CRL cited manufacturing deficiencies at a third-party vendor unrelated to the drug substance or clinical data, with no other safety or efficacy concerns noted. Unicycive plans to seek a Type A meeting with the FDA to resolve the issues promptly and is optimistic due to a backup manufacturing vendor with a strong regulatory track record already producing the drug product. Oxylanthanum carbonate utilizes nanoparticle technology to potentially improve adherence by lowering pill burden compared to existing phosphate binders.