Pfizer announces submission of new drug application to the U.S. FDA for Paxlovid

30 June 2022 - Final results from EPIC-HR study showed an 86% reduction in relative risk of hospitalisations or death from ...

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Accuretic supply issue, almost 36,000 New Zealanders taking the blood pressure medicine will need to change treatments

30 June 2022 - PHARMAC has updated health care professionals that supply of quinapril with hydrochlorothiazide (branded as Accuretic), from supplier ...

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Maviret (glecaprevir/pibrentasvir) approved by Health Canada for paediatric patients with chronic hepatitis C

22 June 2022 - This approval is supported by 98.4 per cent cure rate across this group of patients who ...

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Slow release potassium bicarbonate–potassium citrate for treating distal renal tubular acidosis

21 June 2022 - The Department of Health and Social Care has asked NICE to produce guidance on using slow-release ...

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TGA approves Vyxeos

15 June 2022 - This marks the first TGA approval for Jazz Pharmaceuticals. ...

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Amylyx Pharmaceuticals announces Health Canada approval of Albrioza for the treatment of ALS

13 June 2022 - Health Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ...

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Amylyx Pharmaceuticals receives notification of PDUFA date extension for AMX0035 for the treatment of ALS

3 June 2022 - New PDUFA goal date scheduled for 29 September 2022 to allow time to review additional data ...

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Thousands sign petition demanding 35 kids with cystic fibrosis be given life-saving drug Kaftrio

2 June 2022 - 'The lives of our children are at stake here, and we need to have this drug'. ...

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Pfizer granted FDA fast track designation for ervogastat/clesacostat combination for the treatment of non-alcoholic steatohepatitis

26 May 2022 - Pfizer today announced the U.S. FDA has granted fast track designation to Pfizer’s investigational combination therapy ...

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AbbVie submits new drug application to U.S. FDA for investigational ABBV-951 (foscarbidopa/foslevodopa) for the treatment of advanced Parkinson's disease

20 May 2022 - Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of ...

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Women with moderate to severe fibroids set to be offered new one a day treatment following final draft guidance from NICE

13 May 2022 - Around 4,500 women with uterine fibroids will be eligible for a new oral treatment after NICE recommended ...

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Phathom Pharmaceuticals announces FDA approval of Voquenza Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquenza Dual Pak (vonoprazan, amoxicillin) for the treatment of H. pylori infection in adults

3 May 2022 - U.S. commercial launch anticipated in the third quarter of 2022. ...

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Mum and son hold their breath for cystic fibrosis drug Trikafta ahead of Budget

29 April 2022 - Hamish Mountfort is a smart, well-spoken and confident 22-year-old who’s dying, literally, to dedicate his life ...

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Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 years with at least one F508del mutation

20 April 2022 - Vertex has submitted this indication to CADTH & INESSS for health technology assessments. ...

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Evusheld receives Health Canada approval for pre-exposure prophylaxis (prevention) of COVID-19 in immune-compromised individuals

14 April 2022 - Evusheld is the first long-acting antibody combination to receive Health Canada authorisation for the prevention of ...

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