Lynparza approved in Japan as adjuvant treatment for patients with BRCA mutated HER2 negative high-risk early breast cancer

25 August 2022 - First and only approved medicine targeting BRCA mutations in early breast cancer ...

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AB Science announces that it has filed an application for conditional marketing authorisation to EMA for masitinib in the treatment of ALS

24 August 2022 - AB Science today announced that it has filed an application for conditional marketing authorisation to the EMA ...

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Children with chronic graft versus host disease may now be prescribed Imbruvica (ibrutinib)

24 August 2022 - This is the first approved treatment option for children with cGVHD under 12 years of age and ...

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Lifesaving cancer treatment out of reach for rural people

23 August 2022 - CAR T-cell therapy eradicates cancer in some patients but remains inaccessible to people who live far from ...

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Prescription medicines: applications under evaluation

24 August 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...

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Roche withdraws application for Tecentriq

25 August 2022 - Publication of AusPAR reveals the withdrawal of the application in July 2021. ...

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FDA approves ibrutinib for paediatric patients with chronic graft versus host disease, including a new oral suspension

24 August 2022 - Today, the FDA approved ibrutinib (Imbruvica, Pharmacyclics) for paediatric patients ≥ 1 year of age with ...

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Access criteria for new COVID-19 treatment announced

25 August 2022 - PHARMAC has today confirmed the access criteria for the first preventative medicine for COVID-19, tixagevimab and cilgavimab ...

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How a long-overlooked protein could remake neuroscience drug discovery — or plunge the FDA into controversy

24 August 2022 - So, imagine you get punched in the head. Not once, but a bunch of times. ...

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Avalglucosidase alfa for treating Pompe disease

24 August 2022 - NICE has published evidence-based recommendations on the use of avalglucosidase alfa for the treatment of patients ...

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The EU HTA regulation: a new frontier for access to innovative technologies

23 August 2022 - A new health technology regulation is due to be applied to help EU countries determine the effectiveness ...

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Health Canada approves Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment for adult patients with resectable non-small-cell lung cancer

23 August 2022 - First and only immunotherapy-based treatment for use before surgery for non-small-cell lung cancer in Canada. ...

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Hiring and data: how the US will set up new Medicare drug price talks

23 August 2022 - The US Government will soon begin hiring experts and collecting the data needed to launch direct ...

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AstraZeneca's Soriot warns new US drug price law will hurt innovation

23 August 2022 - AstraZeneca's Chief Executive Pascal Soriot warned on Tuesday new US legislation capping drug prices would reduce ...

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European Medicines Agency commences review of oral fixed-dose combination of decitabine and cedazuridine for the treatment of adults with acute myeloid leukaemia

22 August 2022 - Otsuka and Astex Pharmaceuticals today announce that the EMA has accepted the marketing authorisation application for the ...

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