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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FDA approves IsoPSA - Cleveland Diagnostics’ novel blood based prostate cancer test

1 December 2025 - Cleveland Diagnostics announced today that the US FDA has approved the company’s IsoPSA in vitro diagnostic ...

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Pre-filled syringe presentation of Byooviz, Samsung Bioepis’ biosimilar to Lucentis (ranibizumab), gains European approval

2 December 2025 - Samsung Bioepis today announced that the EMA’s CHMP has adopted a positive opinion for Byooviz pre-filled syringe, ...

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High risk early breast cancer patients in Quebec left behind by recent INESSS recommendation

3 December 2025 - Quebec has the highest rate of breast cancer in Canada. The Government of Quebec recently endorsed lowering ...

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Incannex granted FDA fast track designation for IHL-42X in obstructive sleep apnea

3 December 2025 - Incannex Healthcare announces that the US FDA has granted fast track designation for IHL-42X, the Company’s ...

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DUSC utilisation analysis public release documents (June 2025)

3 December 2025 - The utilisation analysis public release documents from the June 2025 DUSC meeting are now available. ...

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FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma

3 December 2025 - Today, the FDA granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with ...

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To avoid tariffs, UK agrees to Trump’s demand to pay more for drugs

3 December 2025 - President Trump has complained that wealthy countries like Britain pay too little for drugs, leading America to ...

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Australia in talks with US over Trump demands to pay more for medicine

2 December 2025 - Australia is talking to the Trump administration and global drug companies about the United States’ push ...

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New hope for rare cancer patients as first immunotherapy treatment subsidised

3 December 2025 - An immunotherapy treatment for a potentially disfiguring form of head and neck cancer has been added to ...

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Anzupgo (delgocitinib cream) now available in Canada for adult patients living with moderate to severe chronic hand eczema

2 December 2025 - Leo Pharma is pleased to announce the availability of Anzupgo (delgocitinib cream) across Canada for adults ...

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Ionis receives US FDA breakthrough therapy designation for zilganersen for Alexander disease

2 December 2025 - On track to submit new drug application in Q1, 2026. ...

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Sangamo Therapeutics receives US FDA fast track designation for ST-503 for the treatment of small fibre neuropathy

2 December 2025 - Sangamo Therapeutics today announced that the US FDA has granted fast track designation to ST-503, an investigational ...

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Arrowhead Pharmaceuticals receives FDA breakthrough therapy designation for plozasiran in severe hypertriglyceridaemia

2 December 2025 - Arrowhead Pharmaceuticals today announced that the US FDA has granted breakthrough therapy designation to investigational plozasiran as ...

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Baxdrostat new drug application accepted under FDA priority review in the US for patients with hard to control hypertension

2 December 2025 - Submission based on positive BaxHTN Phase 3 trial results which demonstrated statistically significant and clinically meaningful reduction ...

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Korea eases path to breakthrough drugs with flexible ICER rules

1 December 2025 - The Government has unveiled a large-scale overhaul of the health insurance drug pricing system, proposing flexible ...

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