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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Merck granted fast track designation by the US FDA for MK-2214 for the treatment of Alzheimer's disease

1 December 2025 - MK-2214, an investigational novel antibody targeting phosphorylated serine 413 (pS413) tau. ...

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New Zealand Pharmaceutical Schedule - 1 December 2025

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

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Ionis receives US FDA breakthrough therapy designation for olezarsen for severe hypertriglyceridaemia

1 December 2025 - On track to submit supplemental new drug application by end of year. ...

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Sound Pharmaceuticals receives FDA breakthrough therapy designation for SPI-1005 to treat Meniere’s disease

1 December 2025 - Sound Pharmaceuticals is pleased to announce that the FDA has granted its investigational new drug, SPI-1005, breakthrough ...

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Cullinan Therapeutics receives FDA fast track designation for CLN-049, a novel FLT3xCD3 T cell engager, in relapsed/refractory acute myeloid leukemia

1 December 2025 - Cullinan Therapeutics today announced that the US FDA has granted fast track designation to CLN-049 for ...

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Vanda Pharmaceuticals provides regulatory update on tradipitant for motion sickness

28 November 2025 - Vanda Pharmaceuticals today announced updates regarding tradipitant for motion sickness. ...

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Lilly lowers the price of Zepbound (tirzepatide) single-dose vials

1 December 2025 - Eli Lilly announced Zepbound (tirzepatide) single dose vials will now be available at lower prices on LillyDirect, ...

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Changes to NICE’s cost effectiveness thresholds confirmed

1 December 2025 - The Government has today announced that it will increase the thresholds NICE uses in evaluations of new ...

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Schedule of Pharmaceutical Benefits - 1 December 2025

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

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Korea launches sweeping drug pricing reform to curb generic dominance

29 November 2025 - The Government will launch a large scale overhaul of the drug pricing system starting in the ...

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CMS Delivers Savings for Seniors on 15 Major Drugs for Cancer and Chronic Disease

25 November 2025 - CMS today announced a net savings of 44%, or $12 billion, from last year’s negotiated Medicare ...

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Government considers new PBS fund to slash wait times for treatments

29 November 2025 - The Albanese Government could introduce a new health fund by the next federal budget to bankroll ...

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Utilisation of real world evidence in regulatory approvals for multiple myeloma therapies

27 November 2025 - Multiple myeloma is a rare, incurable haematologic malignancy that demands ongoing innovation in treatment approaches given frequent ...

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Easier access to HIV medicines from next year

27 November 2025 - PHARMAC is making a change to ensure everyone who needs HIV medicines can access them more ...

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PHARMAC proposes funding for rare disorder treatment

26 November 2025 - PHARMAC is proposing to fund nitisinone for people with the rare disorders - tyrosinaemia type 1 ...

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