ViiV Healthcare announces US FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV

8 April 2024 - Dovato is now the first and only oral, two drug, single-tablet regimen available for people aged 12 ...

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Relugolix–estradiol–norethisterone acetate for the treatment of patients with pain associated with endometriosis

28 March 2024 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...

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US FDA approves Opsynvi (macitentan and tadalafil) as the first and only once daily single tablet combination therapy for patients with pulmonary arterial hypertension

22 March 2024 - Approval is based on the results from the pivotal Phase 3 A DUE study, which met ...

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18 January 2024 - NICE has published additional draft guidance on the use of remdesivir and the combination of tixagevimab ...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