FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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Bayer's Adempas gets insurance coverage in Korea 11 years after approval

21 May 2025 - The pulmonary arterial hypertension medicine Adempas (riociguat) will be covered by national health insurance starting next ...

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Apotex receives Health Canada approval for Aflivu, a biosimilar to Eylea, available in pre-filled syringe and vial formats

2 July 2025 - Apotex today announced that Health Canada has approved Aflivu (aflibercept), a biosimilar to Eylea, indicated for ...

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FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

2 July 2025 - Today, the FDA granted accelerated approval to sunvozertinib (Zegfrovy, Dizal) for adult patients with locally advanced ...

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Top level push for taxpayer funding of weight loss drugs gathers pace

3 July 2025 - Pharma giants are sweating on the results of a federal government request for guidance on adding weight ...

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Big pharma calls out Australia’s ‘freeloading’ on US medicine

3 July 2025 - American pharmaceutical manufacturers have ramped up pressure on Donald Trump to take action against Australia over its ...

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FDA grants priority review for Winrevair (sotatercept-csrk) to update label based on results from ZENITH trial

2 July 2025 - Merck today announced that the US FDA has accepted and granted priority review for a new supplemental ...

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FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma

2 July 2025 - Today the FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals), a bispecific B-cell maturation antigen ...

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Calls for 'missing piece' menopause drug to be added to the PBS

2 July 2025 - A key treatment which could help around one million middle-aged Australian women remains unaffordable to many ...

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Life-saving breast cancer drug now cheaper thanks to expansion of the PBS

1 July 2025 - A potentially life-saving treatment for early-stage breast cancer will become much more affordable for hundreds of ...

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Adagrasib for adults with previously treated, advanced, KRAS G12C mutation positive non-small-cell lung cancer

2 July 2025 - NICE is unable to make a recommendation on the use of adagrasib (Krazati) for the second-line treatment ...

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New Zealand Pharmaceutical Schedule - 1 July 2025

1 July 2025 - The July 2025 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...

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NICE welcomes the inclusion of measures for equal treatment of medicines and health technologies

1 July 2025 - The new approach will ensure that high impact devices, diagnostics and digital tools recommended by NICE, that ...

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Schedule of Pharmaceutical Benefits - 1 July 2025

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

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Unicycive Therapeutics announces receipt of complete response letter for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis

30 June 2025 - No other concerns stated, including pre-clinical, clinical, or safety data. ...

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Takeda announces US FDA approval of Gammagard Liquid ERC, the only ready to use liquid immunoglobulin therapy with low immunoglobulin A content

30 June 2025 - US commercialisation of Gammagard Liquid ERC projected to begin in 2026. ...

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