Health Canada authorizes P-I clinical trial of Moderna’s mRNA vaccine for Bundibugyo Ebola
Health Canada has authorized Moderna to initiate a P-I clinical trial of its candidate mRNA vaccine for Ebola disease caused by the Bundibugyo virus, a strain currently driving an outbreak in the Democratic Republic of the Congo. The trial will evaluate the vaccine’s safety, dosage range, side effects, and immune response in healthy participants. Canada is the second country after the UK to authorize a Phase I trial for a Bundibugyo vaccine candidate. The authorization marks an early step toward developing a vaccine for a virus for which no licensed vaccine or treatment currently exists.
Québec becomes first province to cover TRYNGOLZA (olezarsen) for familial chylomicronemia syndrome
CELYSTRA Pharma announced that Québec has become the first Canadian province to provide public coverage for TRYNGOLZA (olezarsen), the first treatment approved by Health Canada for familial chylomicronemia syndrome (FCS), a rare genetic disease. TRYNGOLZA is now listed on the Régie de l’assurance maladie du Québec (RAMQ) List of Medications for eligible patients who meet the applicable coverage criteria. The decision expands public access to treatment for Canadians living with FCS and marks an important step toward improving access to therapy for this rare condition.
UBRELVY (ubrogepant) recommended for reimbursement by CDA-AMC for acute migraine treatment
AbbVie announced that Canada’s Drug Agency (CDA-AMC) has recommended UBRELVY (ubrogepant) for reimbursement with conditions by public drug plans for the acute treatment of migraine, with or without aura, in adults. The recommendation supports access to the oral calcitonin gene-related peptide (CGRP) receptor antagonist for eligible patients experiencing migraine attacks. UBRELVY is already approved by Health Canada for the acute treatment of migraine in adults, and the CDA-AMC recommendation represents a step toward broader public reimbursement across Canada.
Merck’s KEYTRUDA (pembrolizumab) approved in Canada for muscle-invasive bladder cancer
Merck announced that Health Canada has approved KEYTRUDA (pembrolizumab) in combination with enfortumab vedotin as neoadjuvant treatment followed by continued adjuvant treatment after radical cystectomy for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. The approval was supported by results from the Phase III KEYNOTE-905 trial, which demonstrated statistically significant improvements in event-free survival, overall survival, and pathologic complete response compared with radical cystectomy and pelvic lymph node dissection alone.
ALK Canada’s neffy now available across Canada for severe allergies
ALK Canada announced that neffy (epinephrine) nasal spray is now available across Canada following its Health Canada approval in April 2026. Approved for adults and children weighing 30 kg or more, neffy is indicated for the emergency treatment of allergic reactions, including anaphylaxis caused by foods, insect stings or bites, medications, and other allergens. The needle-free nasal spray provides an additional epinephrine administration option for Canadians at risk of severe allergic reactions, supporting greater convenience and portability in emergency preparedness.
Regeneron’s LIBTAYO (cemiplimab) approved in Canada for high-risk cutaneous squamous cell carcinoma
Regeneron Canada announced that Health Canada has approved LIBTAYO (cemiplimab) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The approval was supported by the Phase III C-POST trial, in which cemiplimab reduced the risk of disease recurrence or death by 68% compared with placebo. The authorization provides a new adjuvant treatment option for eligible Canadian patients with high-risk CSCC.
Harmony Acquisitions announces proposed qualifying transaction with Vimy Pharmaceuticals
Harmony Acquisitions and Vimy Pharmaceuticals announced a non-binding letter of intent to complete a business combination that would constitute a reverse takeover of Harmony. The proposed transaction is intended to result in the combined company being renamed Vimy Pharmaceuticals Corp. Vimy Pharma is developing a portfolio of generic medicines and has filed an Abbreviated New Drug Submission with Health Canada for a generic version of Ozempic (semaglutide injection), which has been accepted for review. The transaction remains subject to a definitive agreement, financing, regulatory and shareholder approvals, and TSXV acceptance.
Kardium’s Globe Pulsed Field System receives Health Canada approval
Kardium announced that Health Canada has granted a Medical Device Licence for the Globe Pulsed Field System, an integrated cardiac mapping and pulsed field ablation platform for the treatment of paroxysmal atrial fibrillation (AF). The system combines high-density cardiac mapping and ablation in a single catheter-based platform. The approval expands access to the technology for Canadian physicians and patients following its U.S. FDA approval in 2025. Clinical data from the pivotal PULSAR study demonstrated 78% freedom from atrial arrhythmia at one year and no device-related primary safety events.
