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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Multiple myeloma treatments available to more people

2 July 2024 - PHARMAC is making more treatment options available for people with multiple myeloma and other blood disorders. ...

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FDA approves treatment for adults with Alzheimer’s disease

2 July 2024 - The US FDA has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. ...

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ICER publishes evidence report on treatment for anaemia in myelodysplastic syndrome

2 July 2024 - There are significant uncertainties regarding long term efficacy and safety of imetelstat; treatment would achieve common ...

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FDA breakthrough therapy designation reduced late-stage drug development time

1 July 2024 - The FDA’s breakthrough therapy designation program was created to increase patient access to safe and effective therapies ...

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Altos Biologics files for approval of aflibercept biosimilar

1 July 2024 - Alteogen announced on 1 July that its subsidiary, Altos Biologics submitted a marketing authorisation application to ...

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Standardisation of practice on publication of indications in Swiss Public Assessment Report

 1 July 2024 - In order to standardise practice, Swissmedic will in future publish both the proposed and approved indications in ...

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Longboard Pharmaceuticals receives breakthrough therapy designation for bexicaserin

1 July 2024 - Longboard Pharmaceuticals today announced that the FDA has granted breakthrough therapy designation for its investigational drug ...

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SpringWorks Therapeutics completes submission of new drug application to the FDA for mirdametinib for the treatment of children and adults with NF1-PN

1 July 2024 - SpringWorks Therapeutics announced today that the Company has completed the submission of a new drug application to ...

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Idorsia’s Jeraygo (aprocitentan) approved in Europe as first and only ERA for the treatment of resistant hypertension

 1 July 2024 - Jeraygo is a new oral antihypertensive therapy – the first in almost 40 years – that is ...

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Pierre Fabre Laboratories announce granting of European marketing authorisation for Obgemsa (vibegron) in overactive bladder

28 June 2024 - The European Commission has authorised the marketing of Obgemsa (vibegron) by Pierre Fabre Laboratories for the symptomatic ...

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Valneva receives marketing authorisation in Europe for the world’s first chikungunya vaccine Ixchiq

1 July 2024 - 2024 – Valneva today announced that the European Commission has granted marketing authorisation in Europe for Valneva’s ...

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New and expanded PBS listings for breast cancer, leukaemia and lupus treatments

2 July 2024 - Australians with early breast cancer, leukaemia, and types of lupus, and insomnia, will now have access to ...

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Syncromune granted FDA fast track designation for SYNC-T SV-102 for the treatment of metastatic castrate-resistant prostate cancer

1 July 2024 - Syncromune today announced that the US FDA has granted fast track designation for SYNC-T SV-102 therapy, its ...

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Antengene announces Xpovio (selinexor) National Health Insurance Service approval for reimbursement in South Korea

26 June 2024 - The approval of Xpovio by the NHIS in South Korea is the fourth national reimbursement in the ...

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Neurocrine Biosciences announces US FDA accepts new drug applications and grants priority review for crinecerfont for paediatric and adult patients with CAH

1 July 2024 - PDUFA target action dates in late December 2024. ...

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