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 grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran

24 June 2021 - Today, the Therapeutic Goods Administration granted provisional determination to Moderna Australia in relation to the COVID-19 ...

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National Medicines Policy review to begin in August 2021

24 June 2021 - The review of the National Medicines Policy will begin in August 2021. ...

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Coronavirus Australia: is the vaccine rollout designed to be slow and ineffective?

23 June 2021 - Another day, another COVID-19 outbreak. ...

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Access to medicine: the states with the most and least pharmacies per capita

21 June 2021 - Many people live in pharmacy deserts. ...

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FDA chief under fire over Alzheimer’s drug decision

22 June 2021 - US regulator’s approval of controversial treatment shows it is too close to Big Pharma, say critics. ...

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FDA should lead the way on new ALS treatments, not Canada and Europe

22 June 2021 - Following the FDA’s recent decision to give the green light to aducanumab, the first treatment approved ...

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Evio Pharmacy Solutions established to tackle affordability, outcomes, and experience with medications

22 June 2021 - Privately funded venture will offer innovative medication solutions to patients, providers and customers. ...

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Fees and charges: summary from 1 July 2021

23 June 2021 - The TGA is required to recover its costs for all activities that fall within the scope of ...

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Rare disease patient advocates continue battle for affordable drugs

23 June 2021 - Beth Vanstone, mother of local Cystic Fibrosis Warrior Madi Vanstone and director of the CF Get ...

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AstraZeneca to be phased out of Aussie jab rollout

23 June 2021 - The Melbourne-made AstraZeneca vaccine will be phased out of Australia’s COVID-19 jab rollout later this year. ...

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TGA approves first generic pomalidomide

23 June 2021 - The TGA has approved first generic version of Celgene's Pomalyst. ...

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Aducanumab (Aduhelm) information

22 June 2021 - The FDA has posted the CDER’s Office of Neurology’s Summary Review Memorandum describing the agency’s extensive ...

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Price disclosure 2021 October cycle outcomes summary

23 June 2021 - The summary of price disclosure price reductions for the 2021 October cycle has now been published. ...

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Genmab announces that Janssen has received European marketing authorisations for Darzalex (daratumumab) subcutaneous formulation, including for the treatment of patients with newly diagnosed light-chain amyloidosis

22 June 2021 - Janssen received European approval for Darzalex SC (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone ...

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LEO Pharma announces European Commission approval of Adtralza (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis

22 June 2021 - The European Commission regulatory approval is primarily supported by data from the ECZTRA 1, 2 and ECZTRA ...

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