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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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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Pegzilarginase for the treatment of patients 2 years of age and older with arginase-1 deficiency

26 June 2025 - NICE has published additional draft guidance consultation on the use of pegzilarginase in the NHS in ...

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Eylea 8 mg with extended 6 month treatment interval approved in the EU

27 June 2025 - The European Commission has granted a label extension in the EU for Eylea 8 mg (aflibercept 8 ...

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Biocon Biologics receives Health Canada approval for Yesafili (aflibercept); first global launch scheduled for July 2025

27 June 2025 - Biocon Biologics is pleased to announce that Health Canada has granted a Notice of Compliance for Yesafili ...

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Omeros submits narsoplimab marketing authorization application to the EMA for the treatment of TA-TMA

27 June 2025 - Omeros Corporation today announced the recent submission of a marketing authorisation application to the EMA for ...

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