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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Updates from the Health Technology Assessment Policy and Methods Review Reference Committee (August 2023)

14 August 2023 - Additional documents are now available. ...

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Jacobio Pharma announces breakthrough therapy designation from China CDE for KRAS G12C inhibitor glecirasib for the treatment of pancreatic cancer

7 August 2023 - Jacobio Pharma today announced that Jacobio's in house KRAS G12C inhibitor glecirasib was granted breakthrough therapy designation ...

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FDA approves niraparib and abiraterone acetate plus prednisone for BRCA mutated metastatic castration-resistant prostate cancer

11 August 2023 - Today, the FDA approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech), ...

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US FDA designates PYC's lead as a fast track development program

11 August 2023 - The Company is currently evaluating the safety/tolerability and efficacy of an investigational drug candidate with disease-modifying potential ...

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PHARMAC proposes widening access to a brain cancer treatment to help reduce the impact of a discontinuation

11 August 2023 - PHARMAC is proposing to widen access to temozolomide, an oral anti-cancer treatment, for people with a type ...

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Patient and citizen participation at the organisational level in health technology assessment: an exploratory study in five jurisdictions

8 August 2023 - While patient participation in individual health technology assessments has been frequently described in the literature, patient and ...

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Medicine costs to halve after Labor wins 60 day dispensing vote

10 August 2023 - More than six million Australians will have the cost of their medi­cines halved within weeks as ...

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New COVID-19 vaccine and booster shots for this fall to be available by end of September

9 August 2023 - The first new COVID-19 vaccines updated for this fall season are now expected to be available by ...

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US FDA accepts Astellas' sNDA for Cresemba (isavuconazonium sulphate) in children

10 August 2023 - Astellas announced that the US FDA has accepted the company's supplemental new drug application for Cresemba (isavuconazonium ...

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FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma

10 August 2023 - On 9 August 2023, the FDA granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech) for adults with ...

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How a controversial US drug policy could be harming cancer patients worldwide

9 August 2023 - The FDA’s accelerated approval process was designed to help people access life saving drugs.  ...

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PHARMAC’s Rare Disorders Advisory Committee makes new recommendations for funding

10 August 2023 - PHARMAC has published the record of the March Rare Disorders Advisory Committee meeting, sharing details on ...

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Health Canada approves Alhemo (concizumab injection) for the treatment of patients living with haemophilia A with FVIII inhibitors

9 August 2023 - Health Canada has approved a new indication for Alhemo (concizumab injection) for the treatment of Canadian adolescent ...

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Galera receives complete response letter from US FDA for avasopasem manganese

9 August 2023 - The Company remains committed to its goal of bringing avasopasem manganese to patients and intends to meet ...

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FDA approves pralsetinib for non-small-cell lung cancer with RET gene fusions

9 August 2023 - Today, the FDA granted regular approval to pralsetinib (Gavreto, Genentech) for adult patients with metastatic rearranged ...

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