Venatorx and Melinta provide update on status of US new drug application for cefepime-taniborbactam

23 February 2024 - No clinical safety or efficacy issues identified. ...

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TGA approves new medication for treatment of endometriosis symptoms

23 February 2024 - Australian drug regulator gives company green light for tablet – although it won’t be subsidised by Pharmaceutical ...

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AbbVie's Vyalev (foslevodopa/foscarbidopa solution) available for the treatment of advanced Parkinson's disease in Canada

8 February 2024 - In clinical trials, patients taking Vyalev achieved the primary endpoint of a reduction in motor fluctuations ...

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Knight Therapeutics announces launch of Bijuva in Canada

6 February 2024 - Knight Therapeutics announced today the launch of Bijuva (oestradiol and progesterone) capsules in Canada. ...

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Sumitomo Pharma and Pfizer Canada announce availability of Myfembree in Canada

31 January 2024 - In partnership with Sumitomo, Pfizer is proud to announce that supply of Myfembree (relugolix 40 mg, estradiol ...

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Remdesivir and the combination of tixagevimab and cilgavimab for the treatment of patients with COVID-19 disease

18 January 2024 - NICE has published additional draft guidance on the use of remdesivir and the combination of tixagevimab ...

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Advanced melanoma treatment to be added to Pharmaceutical Benefits Scheme

21 January 2024 - Treatment for advanced melanoma is set to become cheaper under the Pharmaceutical Benefits Scheme in the ...

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1.4 million more people at risk of severe COVID-19 to have access to antiviral Paxlovid

11 January 2024 - A further 1.4 million people who have an increased risk for progression to severe COVID-19 will be ...

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Opdualag licensed for patients with advanced melanoma

27 December 2023 - The MHRA has today approved the advanced melanoma medicine Opdualag (nivolumab-relatlimab) for patients from the age of ...

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Duchesnay is seeking Health Canada approval for a segesterone acetate/ethinyl estradiol contraceptive vaginal system, a new option for women

30 November 2023 - Duchesnay has recently filed a new drug submission to Health Canada for its segesterone acetate/ethinyl estradiol slow ...

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Karuna Therapeutics announces US FDA accepts new drug application for KarXT for the treatment of schizophrenia

29 November 2023 - PDUFA action date is 26 September 2024. ...

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Foslevodopa with foscarbidopa for the treatment of patients with advanced Parkinson’s with motor symptoms

29 November 2023 - NICE has published final evidence-based recommendations on the use of foslevodopa with foscarbidopa (Produodopa) for the ...

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Vertex announces EMA validation for marketing authorisation application extension for Kaftrio in combination with ivacaftor to include people with cystic fibrosis and responsive rare mutations

24 November 2023 - Application to add ~200 non-F508del CFTR mutations to the Kaftrio license. ...

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European Commission approves Kaftrio in combination with ivacaftor for the treatment of children with cystic fibrosis ages 2 through 5

23 November 2023 - More than 1,200 children are newly eligible for a medicine that could treat the underlying cause ...

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Zydus receives US FDA approval for Zituvimet to treat adult patients with type 2 diabetes mellitus

6 November 2023 - The company received final approval from the US FDA for its new drug application for Zituvimet ...

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