Nemolizumab SC injection
Trade Name: Nemluvio®
Company: Galderma Canada
Approval Dates/Comments: In January 2026, Health Canada approved nemolizumab, a first-in-class interleukin (IL)-31 inhibitor for two indications: (1) treatment of moderate-to-severe atopic dermatitis (AD) in patients aged ≥12 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable and (2) treatment of adults with moderate-to-severe prurigo nodularis (PN) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. These approvals are based on positive findings from the Phase 3 ARCADIA and OLYMPIA clinical trial programs in AD and PN, respectively.
The Phase 3 ARCADIA 1 and ARCADIA 2 trials met their co-primary endpoints and all key secondary endpoints, demonstrating that nemolizumab, administered every 4 weeks in combination with background topical corticosteroids or topical calcineurin inhibitors (+TCS-TCI), clinically improved skin lesions, and substantially improved itch and sleep disturbance in patients aged ≥12 years with moderate-to-severe AD, vs. placebo +TCS-TCI. Significant itch relief was observed as early as week 1. Furthermore, the ARCADIA long-term extension study showed that nemolizumab was well tolerated and associated with sustained and increased improvements in AD symptoms during prolonged therapy up to 2 years.
The OLYMPIA long-term extension study assessed the safety and efficacy of nemolizumab for PN up to 4 years and included 508 patients from the Phase 2 trial or the Phase 3 OLYMPIA 1 and OLYMPIA 2 trials. Results show that nemolizumab was associated with sustained and clinically meaningful improvements in symptoms of PN during prolonged treatment up to 2 years. At week 100, the interim analysis demonstrated that more than 90% and 70% of evaluable patients achieved at least a 4-point improvement in itch and were itch free or nearly itch free, respectively; at least 80% of patients achieved 76%‑100% healed pruriginous lesions; and approximately 75% reached clearance or almost-clearance of skin nodules when assessed using the Investigator’s Global Assessment score. Nemolizumab was well tolerated in the long-term treatment of PN with no new safety signals identified.
Gepotidacin tablets
Trade Name: Blujepa®
Company: GSK plc
Approval Dates/Comments: The US FDA approved an additional indication for this triazaacenaphthylene antibiotic in December 2025 as an oral therapy for patients ≥12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae (e.g., where standard of care is contraindicated, or where patients are intolerant or unwilling to use first-line treatment). Geopotidacin was first approved in March 2025 to treat urinary tract infections.
Zoliflodacin for oral suspension
Trade Name: Nuzolvence®
Company: Innoviva
Approval Dates/Comments: In December 2025, the FDA approved this first-in-class, spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients ≥12 years of age, weighing at least 35 kg.
