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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Global sarcoma therapy now listed on Pharmaceutical Benefits Scheme

31 July 2023 - Yondelis (trabectedin) demonstrates 45% reduction in risk of disease progression or death versus dacarbazine. ...

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China’s National Medical Products Administration accepts Astellas’ biologics license application for zolbetuximab

31 July 2023 - Astellas Pharma today announced that the Center for Drug Evaluation of the China National Medical Products Administration ...

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Stakeholders want clearer terms in FDA's generally accepted scientific knowledge guidance

31 July 2023 - Drug makers and research groups are generally supportive of the US FDA’s plan to allow greater flexibility ...

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CMS releases 2024 projected Medicare Part D premium and bid information

31 July 2023 - The CMS today announced that the average total monthly premium for Medicare Part D coverage is projected ...

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Drug makers go under the skin, skirting early US Medicare price negotiations

28 July 2023 - Injectable versions of some widely-used cancer drugs including Johnson & Johnson's blockbuster multiple myeloma treatment Darzalex ...

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FDA approves dostarlimab-gxly with chemotherapy for endometrial cancer

31 July 2023 - Today, the FDA approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for ...

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Fair allocation of scarce CAR T-cell therapies for relapsed/refractory multiple myeloma

31 July 2023 - The treatment landscape for relapsed/refractory multiple myeloma has undergone an immunotherapeutic breakthrough with the introduction of ...

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Schedule of Pharmaceutical Benefits - 1 August 2023

1 August 2023 - The August 2023 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

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Bavencio gets coverage as first-line maintenance therapy for urothelial cancer

25 July 2023 - Merck’s anti-PD-L1 immuno-oncology drug Bavencio (avelumab) will get insurance coverage starting next month as first-line maintenance ...

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New Zealand Pharmaceutical Schedule - 1 August 2023

1 August 2023 - The August 2023 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...

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International harmonisation of ingredient names - changes to the PBS Schedule effective 1 August 2023

PBAC - The PBS Schedule has been updated in the 1 August 2023 Schedule to show sole ingredient names for ...

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FDA grants fast track designation to IVS-3001, a CAR-T cell therapy in the treatment of renal cell carcinoma

31 July 2023 - Invectys is pleased to announce the US FDA has granted fast track designation to its revolutionary ...

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US FDA accepts biologics license application for GC Biopharma's GC5107B (immune globulin intravenous (human), 10% liquid)

31 July 2023 - GC Biopharma today announced that the US FDA has accepted the Company's resubmission of the biologics ...

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PHARMAC’s funding model creating an ‘ethical dilemma’ - specialist

29 July 2023 - The New Zealand Breast Cancer Foundation is renewing calls for PHARMAC to fund Keytruda for the ...

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Citius Pharmaceuticals receives a complete response letter from the US FDA for Lymphir (denileukin diftitox) for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma

29 July 2023 - No clinical efficacy or safety issues raised. ...

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