Guselkumab SC use
Trade Name: Tremfya®
Company: Johnson & Johnson
Approval Dates/Comments: The US FDA expanded the approved indications for guselkumab in September 2025 to include the treatment of children aged ≥6 years who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA). This latest decision makes guselkumab the first and only interleukin-23 inhibitor to be approved for these pediatric indications. For plaque PsO, approval was based on results from the phase 3 PROTOSTAR study, a randomized, placebo- and active comparator-controlled trial in pediatric patients. Coprimary endpoints of PASI 90 and IGA score of 0/1 were achieved at week 16. About 56% of patients receiving guselkumab achieved PASI 90 vs. 16% of patients receiving placebo (P < .01). At week 16, 66% of guselkumab-treated patients achieved IGA 0/1 vs. 16% on placebo (P < .001). Complete clearance (IGA 0) was reported in nearly 40% of guselkumab-treated patients vs. 4% on placebo (P < .01). For pediatric PsA, approval was based on pharmacokinetic extrapolation analyses of guselkumab clinical trial data in adults with PsO and PsA, and pediatric patients with plaque PsO, including PROTOSTAR, VOYAGE 1 and VOYAGE 2, and DISCOVER-1 and DISCOVER-2.
Remibrutinib tablets
Trade Name: Rhapsido®
Company: Novartis
Approval Dates/Comments: In September 2025, the FDA approved this first-in-class, oral, targeted Bruton’s tyrosine kinase (BTK) inhibitor as a second-line therapy for chronic spontaneous urticaria, or hives, in patients who remain symptomatic despite H1 antihistamine treatment.
Pembrolizumab + berahyaluronidase alfapmph SC injection
Trade Name: Keytruda Qlex®
Company: Merck
Approval Dates/Comments: The FDA approved a new preparation of this programmed death receptor-1 (PD-1) blocking antibody in September 2025 for subcutaneous (SC) administration in adults across most solid tumor indications. The addition of berahyaluronidase alfa augments dispersion and permeability, thereby enabling SC dosing. Treatment must be administered by a health care provider.
Donidalorsen SC use
Trade Name: Dawnzera
Company: Ionis Pharmaceuticals
Approval Dates/Comments: The FDA approved donidalorsen in August 2025 for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age. This first and only RNA-targeted medication targets and reduces plasma prekallikrein, a key protein that activates inflammatory mediators associated with acute attacks of HAE. Treatment can be self-administered via SC autoinjector once every 4 or 8 weeks.
Garadacimab for SC use
Trade Name: Andembry®
Company: CSL Behring
Approval Dates/Comments: In August 2025, Health Canada granted marketing authorization for garadacimab for routine prevention of attacks of hereditary angioedema in adult and pediatric patients aged ≥12 years. Garadacimab is a monoclonal antibody developed to target activated FXII (FXIIa), a plasma protein that initiates the HAE cascade. It is available as a prefilled pen for SC self-injection.
Lifileucel for IV use
Trade Name: Amtagvi®
Company: Iovance Biotherapeutics
Approval Dates/Comments: In August 2025, Health Canada granted conditional approval for lifileucel, a tumor-derived autologous tumor-infiltrating lymphocyte therapy (TIL), to treat adult patients with unresectable or metastatic melanoma that has progressed after at least one prior systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This is the first T cell therapy for solid tumor cancer.
