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RSS FeedPosted by Michael Wonder on 30 Jun 2022
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 ...
Posted by Michael Wonder on 29 Jun 2022
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 ...
Posted by Michael Wonder on 23 Jun 2022
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 ...
Posted by Michael Wonder on 15 Jun 2022
TGA approves Vyxeos
15 June 2022 - This marks the first TGA approval for Jazz Pharmaceuticals. ...
Posted by Michael Wonder on 13 Jun 2022
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 ...
Posted by Michael Wonder on 04 Jun 2022
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 ...
Posted by Michael Wonder on 02 Jun 2022
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'. ...
Posted by Michael Wonder on 26 May 2022
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 ...
Posted by Michael Wonder on 20 May 2022
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 ...
Posted by Michael Wonder on 13 May 2022
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 ...
Posted by Michael Wonder on 04 May 2022
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. ...
Posted by Michael Wonder on 02 May 2022
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 ...
Posted by Michael Wonder on 20 Apr 2022
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. ...
Posted by Michael Wonder on 15 Apr 2022
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 ...
Posted by Michael Wonder on 14 Apr 2022
U.S. FDA extends review of biologics license application for Regen-Cov (casivirimab and imdemivab) for treatment and prophylaxis of COVID-19
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...