United States & Canada — Health Canada
10 shared events · Importance 5 · Last updated Jun 11, 2026
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Business
United States: The United States' executive order prioritizing psychedelic therapies for accelerated FDA review and expanded patient access has intensified attention on ibogaine, creating a significant market opportunity.
Canada — Health Canada: Canada — Health Canada's regulation of ibogaine under the Food and Drugs Act and its listing on the Prescription Drug List provides a favorable regulatory environment for Optimi Health's operations.
Jun 08, 2026 · 14 articles
Tech
United States: The United States>>> was the location of the U.S.-led study of daraxonrasib and the initial application for drug licensing to the United States — Food and Drug Administration>>>.
Canada — Health Canada: Canada — Health Canada>>> has not yet received an application to license daraxonrasib in Canada>>>. Its role is to regulate and approve new drugs for use in the country, impacting the timeline for Canadian patient access.
May 29, 2026 · 74 articles
Business
United States: The United States is a target market for future clinical research involving Optimi Health's psilocybin product.
Canada — Health Canada: Canada — Health Canada issued the Drug Establishment Licence (DEL) to Optimi Health, authorizing the company's manufacturing, packaging, labeling, testing, storage, and distribution of controlled drug products.
Jun 02, 2026 · 25 articles
Business
United States: The standardized workflow in Canada for ClearPoint Neuro's system is already in use in the United States, allowing for consistency in clinical trials.
Canada — Health Canada: Canada — Health Canada granted the Medical Device License to ClearPoint Neuro for its Neuro Navigation System, facilitating its use in Canadian neurosurgery centers.
Apr 20, 2026 · 6 articles
Business
United States: The United States is one of the countries where Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel has been evaluated in clinical trials and where additional regulatory filings are planned.
Canada — Health Canada: Canada — Health Canada is the regulatory body whose approval is required for Medexus Pharmaceuticals to begin commercializing Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel in Canada.
Jun 10, 2026 · 6 articles
Business
United States: United States>>> is a key market for Diagnosis's CARA platform, with the company pursuing FDA clearance.
Canada — Health Canada: Diagnosis is pursuing regulatory clearance with Canada — Health Canada>>> for its CARA platform, a key milestone for market expansion in Canada.
Jun 05, 2026 · 11 articles
Regulatory
Canada — Health Canada: Canada — Health Canada issued a recall notice for the above-ground pools sold in Canada, aligning with the United States — United States Consumer Product Safety Commission's actions.
Jul 21, 2025 · 24 articles
Regulatory
Canada — Health Canada: Canada — Health Canada issued a corresponding notice for the recall of Ryobi pressure washers in Canada, ensuring consumer safety in the region.
Aug 28, 2025 · 7 articles
Regulatory
Canada — Health Canada: Canada — Health Canada is the regulatory body in Canada to which Diagnosis plans to submit CARA for approval, impacting its commercialization in Canada.
Apr 08, 2026 · 6 articles
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