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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Cost of medicines a key election issue

22 April 2022 - Health and community pharmacy peak bodies have formed a coalition urging parties to recognise medicine affordability ...

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Recommendations made by the PBAC - March 2022

22 April 2022 - The recommendations from the March 2022 PBAC meeting are now available. ...

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European collaboration on health technology assessment: looking backward and forward

19 April 2022 - The establishment of health technology assessment has been an important topic in Europe for many years. ...

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Bridge to Life receives breakthrough device designation from the FDA

21 April 2022 - Bridge to Life advances their perfusion system development with the breakthrough device designation for the LifeCradle ...

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Will the shadow of Aduhelm cloud FDA’s decision-making on an ALS therapy?

21 April 2022 - On March 30, an FDA advisory panel voted 6 to 4 against recommending approval of what ...

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What counts as a breakthrough? 8 insights on the FDA’s approach to medical devices.

21 April 2022 - The word breakthrough carries a kind of weight: it’s a dramatic step forward, a critical advance in ...

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ICER to assess treatments for multiple sclerosis

21 April 2022 - Report will be subject of New England CEPAC meeting in January 2023; draft scoping document open ...

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AbbVie’s Crohn’s disease drug given green light by MHRA

21 April 2022 - An estimated 217,000 people aged 16 and over live with the condition in the UK. ...

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Are high cost prescription drugs the price of innovation? Disclose the costs of clinical trials.

21 April 2022 - With 40% of Americans struggling to afford prescription medicines and many rationing or delaying initiation of lifesaving ...

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Astellas announces reimbursement for Xospata (gilteritinib) in most provinces for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation

21 April 2022 - Having access to an additional treatment option offers hope for Canadian adult AML patients with relapsed ...

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Revance receives FDA acceptance of BLA resubmission for daxibotulinumtoxinA for injection for glabellar lines

21 April 2022 - PDUFA goal date set for 8 September 2022. ...

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Zambon receives U.S. FDA breakthrough therapy designation for CMS I-neb in patients with non-cystic fibrosis bronchiectasis

21 April 2022 - CMS I-neb is an investigational treatment being developed as a potential first-in-class inhaled therapy for adult patients ...

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COVID-19 vaccine weekly safety report (24 April 2022)

24 April 2022 - To 17 April 2022, the TGA has received 534 reports which have been assessed as likely to ...

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Ontario family forced to fight for life-saving drug highlights need for national rare disease strategy

21 April 2022 - Beth Vanstone doesn’t want anyone else to have to fight for access to life saving medications. ...

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Hansa Biopharma granted added benefit ASMR 3 by French Transparency Commission for Idefirix (imlifidase) as desensitisation treatment for highly sensitised kidney transplant patients

20 April 2022 - The opinion by the Transparency Commission follows after Idefirix was granted a funded Early Access Program by ...

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