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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

TGA approves first generic pomalidomide

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

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

Orpathys approved in China for patients with lung cancer and MET gene alterations

23 June 2021 - First-in-class approval in China in this setting and first regulatory approval for the oral, potent and ...

Read more →

PBS listings to support patients with mesothelioma

23 June 2021 - From July 1, thousands of Australians and their families suffering from rare cancers and genetic disorders are ...

Read more →

FDA approved Biogen Alzheimer’s drug despite some staff concerns

22 June 2021 - The agency has faced criticism for approving the drug, Aduhelm, without clear proof it works. ...

Read more →

Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium

22 June 2021 - The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of ...

Read more →

New drug could cost the Government as much as it spends on NASA

22 June 2021 - The Alzheimer’s treatment will cost $56,000 per patient, and millions may use it. The result: “crazy numbers” ...

Read more →

COVID-19 delta strain requires two vaccine doses for protection, Therapeutic Goods Administration boss says

22 June 2021 - Australians will need two doses of a COVID-19 vaccine to adequately protect themselves against the highly ...

Read more →