Schedule of Pharmaceutical Benefits - 1 October 2025

1 October 2025 - The October 2025 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

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Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria

30 September 2025 - Remibrutinib also in clinical development for chronic inducible urticaria, food allergy, and hidradenitis suppurativa, expanding Novartis Immunology ...

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Pfizer reaches landmark agreement with US Government to lower drug costs for American patients

30 September 2025 - Voluntary agreement meets the President’s four requests while also protecting the US ecosystem responsible for America’s leadership ...

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Novo Nordisk submits biologics license application to FDA for Mim8; an investigational, prophylaxis treatment for people living with haemophilia A with or without inhibitors

29 September 2025 - In haemophilia A, denecimig is designed to help the body form blood clots more effectively and was ...

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US FDA approves Tremfya (guselkumab) for the treatment of paediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor

29 September 2025 - Approval was based on PROTOSTAR study, which showed paediatric patients receiving Tremfya achieved high levels of ...

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AbbVie announces UK pricing strategy for Elahere (mirvetuximab soravtansine-gynx)

29 September 2025 - The list price will be consistent with the US to reflect the value of the innovation. ...

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New life changing medicines listed on the PBS

28 September 2025 - From 1 October 2025, Australians affected by breast cancer and rare kidney disease will have access ...

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EMA recommends marketing approval of Gobivaz, Alvotech’s proposed biosimilar to Simponi (golimumab) with Advanz Pharma as commercialisation partner

22 September 2025 - Alvotech and Advanz Pharma today announced that the EMA's CHMP has adopted a positive opinion recommending approval ...

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Donald Trump is waging war on sky-high drug prices. Can he win?

28 September 2025 - Big Pharma has a big headache: Donald Trump. Lately drugmakers have had to contend with the ...

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Major breast cancer treatment cost slashed under new PBS listing

28 September 2025 - Thousands of women will pay significantly less for treatment after the Federal Government listed a leading ...

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Health Minister Mark Butler says PBS not for negotiation, Donald Trump announced 100 pc tariff on pharmaceutical goods

26 September 2025 - Health Minister Mark Butler says Australia’s PBS will be protected at all costs, despite a pending ...

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Crinetics announces FDA approval of Palsonify (paltusotine) for the treatment of adults with acromegaly

25 September 2025 - Approval based on data from two pivotal Phase 3 trials where Palsonify was well tolerated and resulted ...

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AbbVie submits new drug application to US FDA for tavapadon for the treatment of Parkinson's fisease

26 September 2025 - Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's ...

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Evkeeza (evinacumab-dgnb) ANGPTL3 antibody approved in the US for children as young as 1 year old with ultra-rare form of high cholesterol

26 September 2025 - Regeneron Pharmaceuticals today announced that the US FDA has approved Evkeeza (evinacumab-dgnb) ANGPTL3 antibody as an adjunct ...

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Vertex announces key advancements across kidney portfolio

25 September 2025 - Vertex announced today that the FDA has granted breakthrough therapy designation to povetacicept for the treatment of ...

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