Bracco receives Health Canada approval for Vueway injection (gadopiclenol), advancing lower dose MRI contrast imaging

17 April 2026 - Approval marks a major milestone in reducing gadolinium exposure while maintaining diagnostic performance, aligning with clinical guidance ...

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Health Canada approves Cysklar (cysteamine ophthalmic solution) 0.44% for treatment of corneal crystals in people with cystinosis

15 April 2026 - Leadiant Biosciences today announced that Health Canada has approved Cysklar (cysteamine ophthalmic solution) 0.44%, a topical eye ...

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Health Canada approves neffy - the first needle free epinephrine spray for anaphylaxis

15 April 2026 - ALK-Abello today announced that Health Canada has approved neffy 2 mg for the emergency treatment of ...

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Saphnelo subcutaneous approved in Canada for the treatment of systemic lupus erythematosus

13 April 2026 - Health Canada has granted a notice of compliance for Saphnelo (anifrolumab injection) for subcutaneous self-administration via a ...

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Sanofi becomes market authorisation holder for Nuvaxovid in Canada, expanding COVID-19 vaccine choices for Canadians

9 April 2026 - Nuvaxovid, a non-mRNA COVID-19 vaccine, will be made available in Canada by Sanofi for the fall 2026-2027 ...

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Sobi receives Health Canada approval for Empaveli (pegcetacoplan) for the treatment of C3G and primary IC-MPGN

9 April 2026 - Approval supported by Phase 3 52 week VALIANT study demonstrated reduced proteinuria, stabilsed kidney function and ...

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Apotex strengthens osteoporosis care in Canada with Health Canada's approval of Denoza, a denosumab biosimilar

7 April 2026 - Apotex today announced that Health Canada has approved Denoza (denosumab injection), a biosimilar to Prolia, for its ...

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Apotex expands Canadian ophthalmology portfolio with Health Canada's approval of Clobivis (clobetasol propionate ophthalmic suspension, 0.05%)

25 March 2026 - Apotex today announced that Health Canada has approved Clobivis (clobetasol propionate ophthalmic suspension, 0.05%), indicated for ...

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Koselugo approved in Canada for plexiform neurofibromas in adults with neurofibromatosis type 1

9 March 2026 - Approval based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour ...

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Health Canada Approves Ozempic (semaglutide injection) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes

2 March 2026 - Novo Nordisk announced today that Health Canada has approved Ozempic (semaglutide injection) to reduce the risk of ...

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Health Canada approves Keytruda SC, a subcutaneous formulation of pembrolizumab across multiple cancer indications

17 February 2026 - Merck announced today that Health Canada has approved Keytruda SC (pembrolizumab injection), a new subcutaneous formulation of ...

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Price, therapeutic value impact international submission times for new drugs

11 February 2026 - The US tends to receive regulatory submissions earlier and more often than other major international regulators, ...

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BioMarin receives Health Canada Notice of Compliance with conditions for Voxzogo for achondroplasia

11 February 2026 - BioMarin has today announced Health Canada has granted a Notice of Compliance with Conditions for Voxzogo ...

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Pendopharm announces the approval of Yorvipath (palopegteriparatide injection) for the treatment of chronic hypoparathyroidism in adults

6 February 2026 - Pendopharm announced today that Health Canada has granted market authorisation for Yorvipath (palopegteriparatide injection), a parathyroid ...

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Teva Canada announces approval of expanded indication of Ajovy (fremanezumab solution for subcutaneous injection), the first anti-CGRP preventive treatment for paediatric episodic migraine

4 February 2026 - Teva Canada announced today that Health Canada has approved an expanded indication for Ajovy (fremanezumab solution for ...

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