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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Lipocine announces its partner received FDA approval of Tlando

29 March 2022 - Commercial launch expected in 2Q 2022. ...

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Government fails to adequately address medicine affordability for working Australians

29 March 2022 - The cost of medicines will continue to go up unchecked as the Federal Government has failed ...

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Novo Nordisk receives FDA approval of higher-dose Ozempic 2 mg providing increased glycemic control for adults with type 2 diabetes

28 March 2022 - Ozempic demonstrated 2.1% blood sugar reduction and also weight loss in adults with type 2 diabetes ...

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Santhera and ReveraGen start rolling NDA submission to the FDA for vamorolone for the treatment of Duchenne muscular dystrophy

29 March 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce the initiation of a rolling new drug application submission to the ...

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Consequences of US FDA approval decisions in high-income countries

29 March 2022 - Akhade and colleagues highlight the global consequences of approving cancer medicines on the basis of uncertain evidence ...

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Tarlige tablets approved in Japan for treatment of patients with neuropathic pain

28 March 2022 - Daiichi Sankyo today announced that it has obtained approval in Japan to change the indication of ...

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Budget 2022-23 – no ‘big bang’ announcements in health

29 March 2022 - Medicines Australia welcomes tonight’s Budget announcements for new PBS listings and on-going COVID-19 measures. ...

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Record investment in the future of Australia's health system

29 March 2022 - The Australian Government is investing in a stronger health system as part of our plan for a ...

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Neurocrine Biosciences announces regulatory approval of Dysval (valbenazine) for the treatment of tardive dyskinesia in Japan

29 March 2022 - Neurocrine Biosciences today announced that its collaboration partner, Mitsubishi Tanabe Pharma Corporation, has obtained regulatory approval of ...

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Ondexxya approved in Japan for reversal of acute major bleeds in patients on factor Xa inhibitors

29 March 2022 - Ondexxya is the first approved reversal agent specifically for factor Xa inhibitors, providing a major advance ...

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European Medicines Agency commences review of novel gene therapy candidate etranacogene dezaparvovec for people with haemophilia B

29 March 2022 - Marketing authorisation application for etranacogene dezaparvovec will be reviewed under accelerated assessment and has the potential to ...

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Seqirus receives Health Canada approval for expanded age indication of its cell-based quadrivalent influenza vaccine for people as young as six months

28 March 2022 - Seqirus announced today that it has received Health Canada approval of Flucelvax Quad (influenza vaccine), its cell-based ...

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Dupixent (dupilumab injection) now approved in Canada for the treatment of severe asthma in children aged six to 11 years with type 2 inflammation

28 March 2022 - This is the sixth indication for Dupixent in Canada, its second in asthma, and its second in ...

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Te Pāti Māori demand accountability from PHARMAC CE for lie about live saving Trikafta drug cost

28 March 2022 - Today Te Pāti Māori stand in solidarity with the cystic fibrosis community of Aotearoa New Zealand ...

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ICER publishes evidence report on treatments for COVID-19

28 March 2022 - Current evidence suggests all four drugs under review have prices reasonably aligned with patient benefits. ...

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