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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World first cheaper immunotherapy treatment listing for patients with advanced or rare cancers

1 March 2026 - From today, thousands more Australians living with advanced and rare cancers will have access to affordable ...

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More cheaper medicines to help Australians fight complex and chronic illness

2 March 2026 - Australians living with auto-immune disease, lymphoma, Parkinson's, motor neuron disease and cerebral palsy will have access ...

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Schedule of Pharmaceutical Benefits - 1 March 2026

1 March 2026 - The March 2026 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

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EMA CHMP recommends EU approval of Henlius’ pertuzumab biosimilar HLX11

27 February 2026 - Shanghai Henlius Biotech announced that the CHMP of the EMA has adopted a positive opinion recommending the ...

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New PBS listing for immunotherapy cancer drugs Opdivo and Yervoy to be slashed

2 March 2026 - Patients with advanced and rare cancers will be able to access two immunotherapy drugs for just $25, ...

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Eton Pharmaceuticals announces US FDA approval for Desmoda (desmopressin acetate) oral solution

25 February 2026 - Commercial launch expected on 9 March 2026. ...

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US FDA approves BioMarin’s Palynziq (pegvaliase-pqpz) for adolescents 12 years of age and older with phenylketonuria

27 February 2026 - BioMarin today announced that the US FDA has approved the company's supplemental biologics license application for Palynziq ...

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Highlights from the 23-26 February 2026 CHMP meeting

27 February 2026 - The EMA’s CHMP has recommended 12 medicines for approval at its February 2026 meeting. ...

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Asieris announces EMA accepts marketing authorisation application for APL-1702

27 February 2026 - Asieris Pharmaceuticals announced today that its marketing authorisation application for APL-1702 (Cevira) for the treatment of high ...

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Photocure partner Asieris announces that EMA has accepted marketing authorisation application for Cevira in Europe

27 February 2026 - Photocure announces that its partner Asieris Pharmaceuticals communicated today that its marketing authorisation application for Cevira (APL-1702) ...

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Pendopharm announces the commercialisation of Buccolam in Canada

27 February 2026 - Pendopharm is pleased to announce that Buccolam is now available in Canada. ...

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Switzerland’s bitter sweet news for Alzheimer’s patients

27 February 2026 - Swiss medicines regulator Swissmedic was expected to approve two drugs for Alzheimer‘s disease.  ...

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Ontario becomes the first province to publicly reimburse the first targeted oral therapy for adults with grade 2 IDH-mutant glioma

27 February 2026 - Servier Canada announces Ontario coverage of Voranigo under the FAST program. ...

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FDA approves Novo Nordisk's Sogroya as the first and only once weekly, long-acting growth hormone for three additional paediatric indications

27 February 2026 - Novo Nordisk today announced that the US FDA has approved three new indications for once weekly Sogroya ...

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FDA approves once weekly Yuwivel (navepegritide) for children with achondroplasia aged 2 years and older

27 February 2026 - Rare paediatric disease priority review voucher granted in connection with approval. ...

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