Dupilumab SC injection
Trade Name: Dupixent®
Company: Sanofi and Regeneron
Approval Dates/Comments: The US FDA recently approved two new indications for dupilumab, a monoclonal antibody blocking interleukin (IL)-4 and IL-13 receptor signaling. In April 2025, dupilumab was approved for the treatment of adults and adolescents aged ≥12 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. The approval is based on positive results from Phase 3 trials (LIBERTY-CUPID) demonstrating significant reductions in itch severity and urticaria activity with dupilumab vs. placebo. Additionally, in June 2025, dupilumab was approved for the treatment of adults with bullous pemphigoid. Approval was based on data from the LIBERTY-BP ADEPT Phase 2/3 study, with dupilumab achieving sustained remission and reduced disease severity, as well as demonstrating significant improvements in disease control and itch reduction.
Garadacimab-gxii for SC injection
Trade Name: Andembry®
Company: CSL Behring
Approval Dates/Comments: In June 2025, the FDA approved garadacimab-gxii, a first-in-class, once-monthly, self-injectable treatment for the prevention of hereditary angioedema (HAE) attacks in patients aged ≥12 years. This monoclonal antibody is the only prophylactic HAE therapy that targets factor XIIa, a protein that starts the HAE inflammatory cascade. The approval was based on findings from the pivotal VANGUARD trial, which demonstrated an 87% reduction in frequency of HAE attacks with garadacimab vs. placebo.
Roflumilast foam, 0.3%
Trade Name: Zoryve®
Company: Arcutis Biotherapeutics
Approval Dates/Comments: In May 2025, the FDA expanded the approved indications of this once-daily, steroid-free, topical selective phosphodiesterase-4 inhibitor to include the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients ≥12 years of age. Regulatory approval was based on findings from the ARRECTOR study, which demonstrated statistically significant improvements in scalp and body psoriasis symptoms with roflumilast foam vs. placebo with significant reductions in scalp and body itch. Treatment was well-tolerated, with adverse events such as headache, diarrhea, and nausea occurring in <4% of patients.
Ustekinumab-hmny for SC injection
Trade Name: Starjemza®
Company: Bio-Thera Solutions Hikma Pharmaceuticals
Approval Dates/Comments: In May 2025, the FDA approved this human IL-12 and IL-23 antagonist as a biosimilar referencing the originator product Stelara® (ustekinumab, Janssen). The approval covers the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and ulcerative colitis.
Ustekinumab biosimilar SC/IV use
Trade Name: Otulfi®
Company: Fresenius Kabi
Approval Dates/Comments: In May 2025, Otulfi® became commercially in Canada for treating adult patients with multiple inflammatory diseases including moderate to severe plaque psoriasis and active psoriatic arthritis. Health Canada approval was granted in December 2024. In the US, Otulfi® (ustekinumab-aauz) was approved by the FDA in September 2024 and became commercially available in March 2025.
Prademagene zamikeracel gene-modified cellular sheets
Trade Name: Zevaskyn™
Company: Abeona Therapeutics
Approval Dates/Comments: The FDA approved the first and only autologous cell-based gene therapy in April 2025 for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa. Approval was based on the pivotal Phase 3 VIITAL™ study, which demonstrated significant wound healing and pain reduction after a single treatment with a favorable safety profile.
