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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Delivery of Novavax vaccine may be delayed in Australia due to reported manufacturing issues

21 October 2021 - Australians may not get access to the Novavax vaccine this year with reports of manufacturing problems causing ...

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NICE recommends gene silencing therapy for porphyria patients on NHS

21 October 2021 - NICE have recommended the use of givosiran, a gene silencing therapy, on the NHS in England, as ...

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COVID-19 vaccine weekly safety report (21 October 2021)

21 October 2021 - To 17 October 2021, approximately 32.7 million vaccine doses have been given in Australia – 18.3 million ...

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Tasmania's Pharmacy Guild wants antiviral COVID-19 pills available in all pharmacies

20 October 2021 - Tasmania has a stockpile of two different antiviral pill products which are sitting in the Royal ...

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FDA grants breakthrough device designation for Biological Dynamics’ early stage pancreatic cancer detection test

20 October 2021 - Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita ...

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Stealth BioTherapeutics receives refusal to file letter from the FDA

20 October 2021 - Stealth BioTherapeutics today announced that it received a Refusal to File letter from the United States FDA ...

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FDA expands approval of Dupixent (dupilumab) to include children aged 6 to 11 years with moderate to severe asthma

20 October 2021 - Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years ...

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Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges

20 October 2021 - Medical devices are potentially good candidates for coverage with evidence development schemes, as clinical data at market ...

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ICER publishes final evidence report and policy recommendations on therapies for myasthenia gravis

20 October 2021 - Independent appraisal committee found the evidence is adequate to demonstrate that eculizumab and efgartigimod both provide a ...

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Sales of Biogen’s costly new Alzheimer’s drug fall far short of expectations

20 October 2021 - The drug maker Biogen reported on Wednesday that Aduhelm, its new Alzheimer’s drug, brought in $300,000 ...

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Luminopia announces FDA approval of digital therapeutic that uses TV shows to improve vision in children with lazy eye

20 October 2021 - Luminopia One improves vision in children with amblyopia, the leading cause of vision loss in children, and ...

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PHARMAC says all patients who meet criteria will get next generation diabetes drugs, despite concerns

20 October 2021 - PHARMAC says it will fund next generation diabetes drugs for all people with the condition who ...

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TGA approves Brukinsa for another use

20 October 2021 - The second approval for zanubrutinib this month. ...

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Pear Therapeutics launches Pear Prescription Digital Therapeutics Digest, provides roadmap for payer coverage considerations

19 October 2021 - Pear Therapeutics, in collaboration with Avalere Health, today launched the Pear Prescription Digital Therapeutics Digest at ...

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Chiesi Global Rare Diseases announces approval of Ferriprox (deferiprone) in Canada for the treatment of iron overload in sickle cell disease

15 October 2021 - Chiesi Global Rare Diseases announced today that Health Canada has approved Ferriprox (deferiprone) for the treatment of ...

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