A comparative study found Canadian patients waited more than 90 weeks longer than Americans and 65 weeks longer than Europeans for new drugs approved between 2019 and 2025. The report said late submissions to Health Canada, along with price controls and other market factors, were the main drivers.
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
A pooled analysis of five randomized trials found intranasal esketamine improved MADRS scores in adults with TRD in both sexes. Females showed greater improvement and higher odds of treatment-response toward trial end.
Aurobindo Pharma's subsidiaries secured Health Canada approval for bevacizumab biosimilar Bevqolva, an EU distribution deal with STADA for two EMA-approved biosimilars, and US FDA approval for ADQUEY ointment for atopic dermatitis.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Canada's Drug Agency issued a draft recommendation against public drug plan coverage for lecanemab, an Alzheimer's treatment conditionally approved by Health Canada in October 2025, citing cost concerns despite the drug's ability to slow cognitive decline.
Health Canada released proposed Clinical Trials Regulations in December 2025 that would establish a new regulatory framework for drug trials, replacing existing rules with a streamlined, risk-based approach aimed at improving access to innovative therapies.
Cytokinetics launches MYQORZO for obstructive hypertrophic cardiomyopathy following FDA approval, while C4 Therapeutics doses first patient in Phase 2 trial of cemsidomide for relapsed/refractory multiple myeloma.
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
Merck secures regulatory approvals for Keytruda in ovarian cancer and subcutaneous formulation in Canada, while launching AI-driven drug discovery partnership with Mayo Clinic targeting high-need therapeutic areas.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07314905 |
Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) |
NOT_YET_RECRUITING | PHASE3 |
| NCT06788587 |
Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder |
RECRUITING | PHASE2 |
| NCT06606470 |
All Providers Better Communication Skills Program' (ABCs) |
RECRUITING | NA |
| NCT06579170 |
Burden of Recreational Water Illness Due to Exposure to Cyanobacteria and Their Toxins in Freshwater Beaches in Canada |
ACTIVE_NOT_RECRUITING | |
| NCT06413485 |
Canadian Beach Cohort Study |
ACTIVE_NOT_RECRUITING | |
| NCT05614349 |
Canadian Adaptive Platform Trial of Treatments for COVID-19 in Community Settings |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05089786 |
Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001) |
WITHDRAWN | NA |
| NCT05040763 |
PERC Health Canada COVID-19 |
COMPLETED | NA |
| NCT05002699 |
Investigating the Impact of Alzheimer's Disease Diagnostics in British Columbia |
UNKNOWN | |
| NCT04896710 |
COVID-19 Rapid Testing for Self-Administration Among an Asymptomatic Sample |
UNKNOWN | NA |
