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FDA News Recap: May 2025
This FDA News Month in Review provides a round-up of regulatory decisions from May 2025.
Welcome back to our recap of this month's news and updates from the US Food and Drug Administration (FDA)!
May 2025 continued a strong year of regulatory momentum, with the FDA advancing a wide range of novel therapies and access-expanding approvals across specialties. From the first TRPM8 agonist eyedrop for dry eye disease to the first biologic for eosinophilic COPD, the month's decisions reflected a growing emphasis on personalized and precision medicine.
In addition, new delivery platforms and generic options expand medication access to meet diverse patient needs. Here’s a look at the most significant FDA developments from May 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: May 2025
FDA Approves Blue Light Therapy for Actinic Keratosis
On May 16, 2025, BioPharmX announced FDA approval of its blue light therapy device for the treatment of actinic keratosis. Based on clinical trials demonstrating effective lesion clearance with minimal discomfort, this non-invasive photodynamic therapy offers a novel approach for precancerous skin lesions.
FDA Approves Generic Albuterol Sulfate Formulation for Asthma
On May 20, 2025, Teva Pharmaceuticals announced FDA approval of its generic albuterol sulfate inhalation aerosol for the treatment of bronchospasm in patients with reversible obstructive airway disease. Based on bioequivalence studies to the reference listed drug, this approval provides a cost-effective alternative for asthma management.
FDA Approves Mepolizumab for Eosinophilic COPD
On May 22, 2025, GlaxoSmithKline announced FDA approval of mepolizumab (Nucala) for the treatment of eosinophilic chronic obstructive pulmonary disease (COPD). Based on Phase 3 trials showing reductions in exacerbation rates among patients with elevated eosinophil counts, mepolizumab becomes the first biologic approved for this COPD phenotype.
FDA Approves Once-Daily Roflumilast (Zoryve) Foam 0.3% for Scalp and Body Psoriasis
On May 22, 2025, Arcutis Biotherapeutics announced FDA approval of Zoryve (roflumilast) foam 0.3% for the treatment of plaque psoriasis involving the scalp and body in patients aged 12 years and older. Based on positive results from the Phase 3 ARRECTOR trial, the foam formulation offers a non-steroidal, once-daily topical option for hard-to-treat areas.
Related content: Understanding Roflumilast Foam's FDA Approval for Scalp and Body Psoriasis, with Jennifer Soung, MD
FDA Approves Susvimo for Treatment of Diabetic Retinopathy
On May 22, 2025, Genentech announced FDA approval of Susvimo (ranibizumab injection) 100 mg/mL via ocular implant for the treatment of diabetic macular edema (DME). Based on the Phase 3 Pagoda study demonstrating sustained vision improvements with fewer treatments, Susvimo offers the first continuous delivery system for DME, reducing the burden of frequent injections.
FDA Approves Treprostinil Inhalation Powder for PAH and PH-ILD
On May 23, 2025, United Therapeutics announced FDA approval of treprostinil inhalation powder for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Based on clinical trials demonstrating improved exercise capacity and symptom management, this formulation offers a portable and convenient delivery option for patients.
FDA Approves Acoltremon Ophthalmic Solution (Tryptyr) for Dry Eye Disease
On May 28, 2025, Alcon announced FDA approval of Tryptyr (acoltremon ophthalmic solution 0.003%) for the treatment of dry eye disease. Based on late-stage trials demonstrating rapid natural tear production through corneal nerve stimulation, Tryptyr offers a novel mechanism as a TRPM8 receptor agonist to address both signs and symptoms of dry eye disease.
FDA Approves Hydrocortisone Oral Solution for Adrenal Insufficiency
On May 28, 2025, Tildacer announced FDA approval of its hydrocortisone oral solution for the treatment of adrenal insufficiency in pediatric and adult patients. Based on pharmacokinetic studies demonstrating bioequivalence to existing formulations, this ready-to-use liquid provides a dosing alternative for patients unable to swallow tablets.
FDA Approves 12.5 mg Chlorthalidone Tablets for Hypertension
On May 30, 2025, Hikma Pharmaceuticals announced FDA approval of 12.5 mg chlorthalidone tablets for the treatment of hypertension. Based on established efficacy and safety profiles, this lower-dose formulation provides clinicians with additional flexibility in managing blood pressure.
