Dupilumab for SC injection
Trade Name: Dupixent®
Company: Sanofi-Regeneron
Approval Dates/Comments: In April 2026, the USFDA approved dupilumab for children 2-11 years with chronic spontaneous urticaria (CSU) inadequately controlled on H1‑antihistamines, making it the first biologic option for this age group. This expands its 2025 indication for patients ≥12 years. Regulatory approval for this additional indication was based on the LIBERTY‑CUPID Phase 3 program, including two replicate, randomized, double‑blind, placebo‑controlled trials (NCT04180488) in antihistamine‑refractory, anti‑immunoglobulin E-naive patients ≥6 years old. In both trials, dupilumab significantly reduced itch severity and urticaria activity (as measured by the weekly Urticaria Activity Score [UAS7]) vs. placebo at week 24. Rates of well‑controlled disease (UAS7 ≤6) and complete response (UAS7 = 0) were also higher with dupilumab. Safety in children 2-11 years of age was consistent with dupilumab’s established profile across dermatologic and allergic indications. Injection‑site reactions were the most common adverse event; no new safety signals emerged. With this decision, dupilumab now has 9 allergy‑related indications, 5 of which include young children. For clinicians, this approval provides a long‑needed, steroid‑sparing, targeted option for pediatric CSU when antihistamines fail.
Adapalene 0.1% + benzoyl peroxide 2.5% acne treatment
Trade Name: Differin® Epiduo® Acne Gel
Company: Galderma
Approval Dates/Comments: In May 2026, the FDA approved this topical acne product for over‑the‑counter (OTC) use, expanding access to a treatment previously available only by prescription. The gel combines adapalene, a third‑generation retinoid, with benzoyl peroxide, an antimicrobial agent, to address clogged pores, bacteria, and inflammation. It is now a prescription-strength option approved for individuals ≥12 years of age that is available OTC. Clinical studies have demonstrated that the adapalene and benzoyl peroxide combination is more effective than either ingredient alone or a placebo gel. Improvements in inflammatory and non‑inflammatory acne were seen as early as week 1. By week 12, inflammatory lesions were reduced by up to 70%, and long‑term studies have shown sustained benefits, with about a 65% reduction in total lesions maintained over 12 months. The Simulgel™ base helps stabilize the formula, ensure even application, and improve tolerability.
Drug News
In June 2026, bemotrizinol – long used internationally as Tinosorb® S – has become the first new FDA‑approved sunscreen filter in over 20 years. The regulatory agency considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreen products. Bemotrizinol is a photostable, broad‑spectrum UVA/UVB filter (with strong absorption at 310 nm and 340 nm) that may be more effective than older actives like avobenzone. It offers minimal systemic absorption due to its large molecular size, is cleared for use in individuals ≥6 months of age, and enables more cosmetically pleasing, non‑whitening preparations with reduced irritation risk. Bemotrizinol is an organic chemical filter (not a mineral filter like zinc oxide or titanium dioxide), therefore it absorbs UV light rather than sits visibly on top of the skin, enabling preparations that are lightweight and more cosmetically elegant. This approval narrows the gap between traditional and global sunscreen formulations.
Health Canada issued a public advisory in April 2026 that unauthorized injectable peptide products (e.g., melanotan I and II)—often promoted for anti‑aging or skin rejuvenation— pose serious risks, including hormonal disruption, organ damage, and potential tumor development. These unregulated peptides have not been evaluated for safety or quality and should not be used.
