Canada — Health Canada & United Kingdom

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.

United Kingdom: The United Kingdom is the recipient of Optimi Health's first psilocybin export, which will support a planned Phase 2 clinical trial for treatment-resistant depression.

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.

United Kingdom: The United Kingdom is urged to make clinical trials for Daraxonrasib available and fast-track its approval to benefit Pancreatic cancer patients.

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.

United Kingdom: The United Kingdom is one of the countries where additional regulatory filings are planned for Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel.