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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TGA approves Grifols' Xembify

15 July 2022 -  Xembify is yet another presentation of human immunoglobulin. ...

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Chief Medical Officer’s statement on standard of care on COVID-19 oral antiviral treatments in residential aged care facilities

15 July 2022 - A statement from Professor Paul Kelly, Australian Government Chief Medical Officer, about the standard of care on ...

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Marinus Pharmaceuticals sells rare paediatric disease priority review voucher for $110 million

14 July 2022 - Marinus Pharmaceuticals today announced that it has entered into a definitive agreement to sell its rare ...

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Breakthrough treatment to boost life chances for hundreds of people with respiratory cancer

14 July 2022 - The first new mesothelioma treatment to be approved in nearly 15 years will be made available ...

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FDA clears DyAnsys neurostimulation device first relief to treat diabetic neuropathic pain

14 July 2022 - First Relief, a PENS (percutaneous electrical neurostimulation) device, has been cleared by the US FDA for ...

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Thousands of patients to benefit as NHS marks 100th fast tracked cancer drug

14 July 2022 - Thousands of people a year with advanced breast cancer will benefit from a life extending drug ...

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FDA approves crizotinib for ALK positive inflammatory myofibroblastic tumour

14 July 2022 - On 14 July 2022, the FDA approved crizotinib (Xalkori, Pfizer) for adult and paediatric patients one ...

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COVID-19 vaccine safety report (14 July 2022)

14 July 2022 - To 10 July 2022, the TGA has received 609 reports which have been assessed as likely to ...

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Roxadustat for treating symptomatic anaemia in chronic kidney disease

13 July 2022 - NICE has published evidence-based recommendations on the use of roxadustat (Evrenzo) for the treatment of adults ...

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Revolo Biotherapeutics awarded Innovation Passport for ‘1805 in the United Kingdom for the treatment of moderate to severe rheumatoid arthritis

14 July 2022 - Revolo Biotherapeutics today announced that it was awarded an Innovative Medicines Designation, or Innovation Passport, from the ...

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BeiGene provides regulatory update on the U.S. biologics license application for PD-1 inhibitor tislelizumab in second-line oesophageal squamous cell carcinoma

14 July 2022 - Due to COVID travel restrictions, inspections could not be completed during review period. ...

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NICE recommends Piqray and Trodelvy, maintaining 100% approvals of breast cancer drugs since 2018

14 July 2022 - An agreement with the companies on the price of two breast cancer treatments, Piqray and Trodelvy, has ...

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Zai Lab announces acceptance by China’s NMPA of the BLA for efgartigimod for patients with generalised myasthenia gravis

13 July 2022 - Efgartigimod alfa injection is the first accepted BLA submission of an FcRn antagonist for generalised myasthenia gravis ...

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PHARMAC widens access for COVID-19 anti-viral treatments

14 July 2022 - Pharmac has confirmed today that it is further widening access to the three anti-viral treatments it ...

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FDA grants Alpheus Medical orphan drug and fast track designations for novel sonodynamic therapy for brain cancer

13 July 2022 - The company is currently enrolling patients in a multicentre Phase 1 clinical trial for the treatment ...

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