Revisiting the FDA’s accelerated approval pathway

8 September 2025 - After aducanumab’s accelerated approval for Alzheimer's disease, and prompted by long standing concerns regarding the accelerated approval pathway ...

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UK Government, pharma industry fail to agree on medicines payment scheme

28 August 2025 - Negotiations between the UK Government and the pharmaceutical industry have ended without an agreement on changes ...

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Trump’s trade war is not the only threat to cheap PBS medicines

10 August 2025 - Australia’s health system is rightly celebrated for its universal access and cost effectiveness, but its outdated assessment ...

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America’s drug regulator is in turmoil

10 August 2025 - The already fraught oversight of rare disease treatments is becoming politicised. ...

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Labor ‘very concerned’ by Trump pharma threat

7 August 2025 - The Albanese Government says it is “very concerned” after Donald Trump’s latest tariff threat on a key ...

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Labor vows to ‘fight’ as Trump threatens pharma tariffs

8 August 2025 - The Albanese government is vowing to “fight for the PBS” as Donald Trump tries to strong-arm ...

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How Australia is getting tangled in Trump’s fight with big pharma

6 August 2025 - The US president is angry Americans pay more for their medicines. Will he want the PBS – ...

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Why drug prices for some big medicines will remain high for a longer time

3 August 2025 - Little known provisions in the Big Beautiful Bill lobbied by industry will cost Medicare billions in missed ...

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FDA approves Alhemo as once daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with haemophilia A or B without inhibitors

31 July 2025 - FDA approval is based on phase 3 trial data (explorer8), which established the safety and efficacy of ...

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Trump takes aim at ‘foreign freeloading nations’ over drug prices in new threat to PBS

1 August 2025 - US President Donald Trump has blamed “foreign freeloading nations” for the high drug prices faced by ...

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Australia’s PBS must ‘absolutely’ be protected in trade talks, says Make America Healthy Again medical adviser Aseem Malhotra

26 July 2025 - The chief medical adviser to Make America Healthy Again campaign has defended Australia’s PBS, as the Trump ...

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Pfizer broadside on PBS productivity amid pharma tariff fears

16 July 2025 - Multinational conglomerate Pfizer has accused the PBS of “under­valuing” medical products in a submission to the ...

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Labor and Coalition in lockstep as Trump threatens to pull pharma tariffs forward

16 July 2025 - US President Donald Trump’s threat to bring forward planned tariffs of up to 200% on pharmaceuticals ...

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FDA embraces radical transparency by publishing complete response letters

10 July 2025 - The US FDA today published more than 200 decision letters, known as complete response letters.  ...

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FDA to issue new Commissioner’s national priority vouchers to companies supporting US national interests

17 June 2025 - The US FDA today announced its Commissioner’s National Priority Voucher program to enhance the health interests of ...

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