Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for people with cystic fibrosis aged 2 years and older with certain rare mutations

15 July 2024 - Approximately 200 people with certain rare CF mutations are now eligible for Trikafta. ...

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Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis

2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...

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AbbVie provides US regulatory update on ABBV-951 (foscarbidopa/foslevodopa)

25 June 2024 - AbbVie continues to work with the FDA to bring ABBV-951 to patients in the US as ...

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Vertex announces extended long-term reimbursement agreement with NHS England for access to cystic fibrosis medicines Kaftrio, Symkevi and Orkambi

20 June 2024 - Agreement includes access to any future licence extensions. ...

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Trifluridine with tipiracil hydrochloride in combination with bevacizumab for the treatment of patients with metastatic colorectal cancer after two systemic treatments

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

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Johnson & Johnson submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Prezcobix

4 June 2024 - Johnson & Johnson today announced the submission of a supplemental new drug application to the US FDA ...

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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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