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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Monkeypox patients should not be left to suffer when an FDA approved drug could help

15 July 2022 - Andy couldn’t sleep more than a couple fitful hours a night because it felt like a ...

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UK lags behind EU in authorising new medicines after Brexit

14 July 2022 - Experts attribute shortfall to small size of British market now it is regulated separately and complexity of ...

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PBAC Public Summary Documents (first time rejections and deferrals) – March 2022 meeting

15 July 2022 - The Public Summary Documents (first time rejections and deferrals) from the March 2022 PBAC meeting are now ...

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Health Canada authorises use of Moderna COVID-19 vaccine in children 6 months to 5 years of age

14 July 2022 - Today, Health Canada authorised the use of the Moderna Spikevax COVID-19 vaccine in children 6 months to ...

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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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