Differin Epiduo Acne Gel Transitions to OTC Status
On May 22, 2026, the US Food and Drug Administration (FDA) approved Galderma’s Differin® Epiduo® Acne Gel (adapalene 0.1%/benzoyl peroxide 2.5%) for over-the-counter (OTC) use for the treatment of acne vulgaris in patients aged 12 years and older. Previously a prescription product, this marks a shift meant to broaden access. The topical gel leverages a dual-mechanism approach by combining a third-generation retinoid with an antimicrobial to address follicular plugging, bacterial proliferation, and inflammation. Approval was supported by more than 15 years of real-world use and a robust clinical program demonstrating that the combination provides greater efficacy than either component alone, with studies showing substantial reductions in inflammatory and non-inflammatory lesion counts and favorable tolerability profiles. The recommended dose is once-daily topical application to affected areas. Common precautions include localized irritation (e.g., erythema, dryness, burning), particularly early in therapy. The product is expected to be available OTC beginning summer 2026.
Linzess Approval Extended to Children Aged 2 and Older with Functional Constipation
The FDA approved Ironwood Pharmaceuticals’ Linzess® (linaclotide) capsules for the treatment of functional constipation (FC) in pediatric patients aged two years and older, expanding prior approval from patients aged six years and older on May 27, 2026. Linzess is an oral guanylate cyclase-C agonist that increases intestinal fluid secretion and accelerates transit. It can be administered by swallowing capsules or mixing contents with applesauce or water to support flexible use in younger children. It remains the only FDA-approved prescription therapy for pediatric FC. Approval was supported by demonstrating improved spontaneous bowel movement frequency versus placebo, with a safety profile consistent with prior adult and pediatric studies. The recommended dose in pediatric populations is 72mcg orally once daily, with safety considerations consistent with known risks, including diarrhea and a contraindication in patients younger than two years of age due to dehydration risk. Here is the updated prescribing information.
Imfinzi Expands into Earlier-Stage Bladder Cancer
On May 28, 2026, the FDA approved AstraZeneca’s Imfinzi® (durvalumab) intravenous (IV) infusion in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients who have BCG–naïve, high-risk non–muscle-invasive bladder cancer (NMIBC). The programmed-death ligand (PD-L)1–blocking immunotherapy, administered with intravesical BCG, is intended to enhance antitumor immune response and improve disease control in this early-stage setting. Approval was based on a statistically significant improvement in disease-free survival compared with BCG alone, reducing the risk of recurrence or death by approximately 32%. The recommended dose of Imfinzi is 1500mg (for patients weighing at least 30kg) or 20mg/kg (for patients weighing less than 30kg) administered every four weeks in combination with BCG induction and maintenance therapy. Treatment should continue for up to 13 cycles, until disease recurrence, progression, or unacceptable toxicity. The updated prescribing information can be found here.
Tremfya Adds Structural Damage Endpoint to Psoriatic Arthritis Label
The FDA approved Johnson & Johnson’s Tremfya® (guselkumab) for an expanded indication to include inhibition of progression of structural joint damage in adults who have active psoriatic arthritis (PsA) on May 28, 2026. Initially approved in 2020 for psoriatic arthritis, this label expansion includes a key outcome from the clinical trials and is the first interleukin‑23 (IL‑23) inhibitor with evidence demonstrating reduced radiographic progression of joint damage. Approval was supported by data showing that Tremfya significantly improved joint symptoms and inhibited structural joint damage progression at 24 weeks versus placebo, with continued benefits demonstrated by a 57% reduction in radiographic progression through 48 weeks in patients who switched from placebo. Tremfya, a dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, targets key drivers of immune-mediated inflammation. The recommended dosing for PsA is 100mg administered subcutaneously (SC) at weeks zero and four, then every eight weeks thereafter. Full prescribing information is available here.