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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Hansa Biopharma submits BLA to FDA for imlifidase in desensitisation for kidney transplantation

19 December 2025 - The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in ...

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Knight Therapeutics announces Health Canada approval for Wynzora to treat psoriasis vulgaris

18 December 2025 - Knight Therapeutics announced today that Health Canada has approved Wynzora, a white uniform cream containing 0.05 ...

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Two new treatments recommended for people with breast cancer

19 December 2025 - Breast Cancer Network Australia welcomes the PBAC's recommendation to subsidise two important medicines on the PBS: Veoza ...

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Weight loss drug Wegovy close to PBS approval

19 December 2025 - New medicines are revolutionising the management of serious medical conditions. Now a recommendation has been made about ...

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European Commission approves Tremfya (guselkumab) for the treatment of children with plaque psoriasis, marking the first paediatric indication for an IL-23 inhibitor

19 December 2025 - The decision is supported by the Phase 3 PROTOSTAR study, where guselkumab demonstrated higher levels of skin ...

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US FDA approves Jascayd (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults

19 December 2025 - Boehringer Ingelheim’s Jascayd (nerandomilast) tablets has been approved by the US FDA for the treatment of progressive ...

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Novartis and US Government reach agreement on lowering drug prices in the US

19 December 2025 - Additional Novartis medicines will be made available through direct to patient platforms in 2026. ...

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Eli Lilly cuts price of diabetes, weight loss drugs in Canada

17 December 2025 - Eli Lilly is slashing the prices of its popular diabetes and weight loss drugs Mounjaro and ...

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FDA grants two national priority vouchers

19 December 2025 - The US FDA today awarded national priority vouchers under the Commissioner’s National Priority Voucher pilot program ...

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The IQWiG methods: new version is effective immediately

19 December 2025 - With the General Methods 8.0, the new IQWiG methodology for determining minimum staffing levels for service ...

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BMS announces agreement with US Government to improve affordability and access to critical medicines for Americans

19 December 2025 - Eliquis (apixaban), the nation’s #1 prescribed oral blood thinner, soon available for free to Medicaid program. ...

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Cytokinetics announces FDA approval of Myqorzo (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms

19 December 2025 - FDA Approval based on results of SEQUOIA-HCM. ...

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Egetis Therapeutics initiates new drug application in the USA for Emcitate (tiratricol) for MCT8 deficiency

19 December 2025 - Egetis Therapeutics today announced that the Company has initiated a rolling new drug application submission to ...

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Recommendations made by the PBAC - November 2025

19 December 2025 - Recommendations made by the PBAC in November 2025 relating to the listing of medicines on the ...

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Sangamo Therapeutics initiates rolling submission of BLA to US FDA for ST-920 in Fabry disease

18 December 2025 - Sangamo expects to complete biological license application submission under accelerated approval pathway in second quarter of ...

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