Outcomes from the December 2024 PBAC meeting

31 January 2025 - Recommendations made by the PBAC in December 2024 relating to the listing of medicines on the PBS ...

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Axsome Therapeutics announces FDA approval of Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults

30 January 2025 - A single oral dose of Symbravo provided rapid migraine pain freedom and return to normal functioning within ...

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Vertex announces FDA approval of Journavx (suzetrigine), a first in class treatment for adults with moderate to severe acute pain

30 January 2025 - Journavx is the first and only approved non-opioid oral pain signal inhibitor and the first new class ...

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Santhera’s Duchenne muscular dystrophy drug Agamree accepted by SMC

16 January 2025 - The rare muscle wasting disorder affects approximately 2,500 males in the UK at any one time. ...

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FDA approves Ozempic (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease

28 January 2025 - The approval is based on the results of the pivotal FLOW Phase 3b kidney outcomes trial and ...

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January 2025 decisions

13 January 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...

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Apellis receives approval of Syfovre (pegcetacoplan) in Australia for geographic atrophy

27 January 2025 - Apellis Pharmaceuticals announced today that the TGA has approved Syfovre (pegcetacoplan) for the every-other-month treatment of adult ...

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Enhertu approved in the US as first HER2 directed therapy for patients with HER2 low or HER2 ultralow metastatic breast cancer following disease progression after one or more endocrine therapies

27 January 2025 - Based on DESTINY-Breast06 phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with a ...

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FDA approves Leqembi (lecanemab-irmb) IV maintenance dosing for the treatment of early Alzheimer's disease

26 January 2025 - Once every four weeks maintenance dosing may be easier for patients and care partners to continue ...

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Garadacimab (Andembry) approved to prevent angioedema attacks

24 January 2025 - The MHRA has today approved garadacimab (Andembry) for patients aged 12 years and older with hereditary angioedema ...

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Australia’s TGA approves registration of CSL’s Andembry (garadacimab) for the prevention of recurrent hereditary angioedema attacks

24 January 2025 - This regulatory approval for registration in Australia is the first in the world for Andembry. ...

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Vadadustat for the treatment of adults with symptomatic anaemia on dialysis for chronic kidney disease

23 January 2025 - NICE has published final evidence-based recommendations on the use of vadadustat (Vafseo) for the treatment of ...

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Medexus announces FDA approval of Grapafex (treosulphan) for injection

22 January 2025 - Medexus will target a commercial launch in 1H CY2025; potential for annual product-level revenue to exceed ...

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Sarclisa approved in the EU as the first anti-CD38 therapy in combination with standard of care VRd to treat transplant-ineligible newly diagnosed multiple myeloma

22 January 2025 - Approval is based on positive results from the IMROZ Phase 3 study, demonstrating Sarclisa in combination with ...

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NICE has made six times more lung cancer treatment recommendations over the past ten years than in the previous decade

21 January 2025 - We have also recommended osimertinib for routine use on the NHS today. ...

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