Recommendations made the PBAC – July 2025

22 August 2025 - The recommendations from the July 2025 PBAC meeting are now available. ...

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Committee rejects application for medication Keytruda to be subsidised for Aussies with cancer

23 August 2025 - Australians with rare cancers like Natalie Willacy have just been handed a devastating hit, which could leave ...

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Injectable form of Ocrevus for relapsing remitting multiple sclerosis recommended for PBS listing

22 August 2025 - This new form of ocrelizumab is given as an injection under the skin (subcutaneously), takes a much ...

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New Alzheimer’s drug rejected for PBS listing, leaving patients to pay up to $80k a year

23 August 2025 - New Alzheimer’s drug rejected for PBS listing, leaving patients to pay up to $80k/year. ...

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Health Canada grants marketing authorisation for an additional indication of Bayer's Nubeqa (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer

21 August 2025 - Bayer is pleased to announce that Health Canada has granted marketing authorisation for its oral androgen receptor ...

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Dawnzera (donidalorsen) approved in the US as first and only RNA targeted prophylactic treatment for hereditary angioedema

21 August 2025 - Offers longest dosing option for hereditary angioedema, with dosing every 4 or 8 weeks. ...

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First of its kind Ozempic listing for kidney disease

19 August 2025 - Regulators have approved Ozempic’s use for kidney disease treatment, opening the door to new combination therapies. ...

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Madrigal receives European Commission approval for Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis

19 August 2025 - Conditional marketing authorisation is based on positive results from the pivotal Phase 3 MAESTRO-NASH trial demonstrating Rezdiffra ...

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Health Canada approves dual immunotherapy Opdivo plus Yervoy for colorectal and liver cancers

19 August 2025 - Bristol Myers Squibb Canada today announced that Health Canada has approved Opdivo (nivolumab) in combination with ...

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Health Canada approves Ozempic to reduce the risk of sustained eGFR decline, end stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease

19 August 2025 - Novo Nordisk announced today that Ozempic (semaglutide injection) is now approved as the first and only ...

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PTC Therapeutics receives complete response letter for vatiquinone NDA

19 August 2025 - PTC Therapeutics announced today that the US FDA has issued a complete response letter related to ...

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Pfizer Canada and BioNTech receive Health Canada approval of LP.8.1 variant adapted COVID-19 vaccine

18 August 2025 - LP.8.1 variant adapted COVID-19 vaccine Cominaty is now authorised in Canada for individuals 6 months of age ...

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Iovance’s Amtagvi (lifileucel) receives Health Canada approval for advanced melanoma

18 August 2025 -  Iovance Biotherapeutics today announced Health Canada has issued a Notice of Compliance with Conditions for Amtagvi ...

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Valneva’s chikungunya vaccine Ixchiq now authorised in Canada for individuals aged 12 and plder

18 August 2025 - Valneva today announced that Health Canada has granted marketing authorisation for its single dose vaccine, Ixchiq, ...

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European Commission grants approval of Ogsiveo

18 August 2025 - Merck KGaA announced today that the European Commission granted marketing authorisation for Ogisiveo (nirogacestat), an oral gamma ...

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