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RSS FeedPosted by Michael Wonder on 11 Nov 2020
Sebela Pharmaceuticals receives FDA approval for Sutab tablets for colonoscopy preparation
10 November 2020 - Sebela Pharmaceuticals today announces that the U.S. FDA approved Sutab (sodium sulphate, magnesium sulphate and potassium chloride) ...
Posted by Michael Wonder on 11 Nov 2020
Therapeutic Goods Administration gives green light for early Pfizer vaccine
11 November 2020 - The nation’s medicines regulator has paved the way for an early release of Pfizer’s breakthrough COVID-19 ...
Posted by Michael Wonder on 10 Nov 2020
Manufacturer moves to bring 'life-changing' cystic fibrosis drugs to Canada
10 November 2020 - A pharmaceutical company says it's taking steps to bring cystic fibrosis drugs to Canada in a ...
Posted by Michael Wonder on 10 Nov 2020
Health Canada approves Maviret 8 week treatment duration for treatment naïve patients with genotype 3 compensated cirrhosis
10 November 2020 - Maviret (glecaprevir/pibrentasvir) is the only 8 week oral treatment approved for all hepatitis C virus genotypes. ...
Posted by Michael Wonder on 10 Nov 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of pancreatic cancer
10 November 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 10 Nov 2020
Supernus provides regulatory updates for SPN-812 and SPN-830
9 November 2020 - The U.S. FDA has issued a complete response letter regarding the new drug application for SPN-812 ...
Posted by Michael Wonder on 10 Nov 2020
The next big challenge after a COVID-19 vaccine is giving it to enough people
10 November 2020 - With Pfizer’s COVID-19 vaccine on track to be authorised as early as next month, Western governments ...
Posted by Michael Wonder on 10 Nov 2020
Pfizer’s and BioNTech’s vaccine is the start of the end of the pandemic
9 November 2020 - Its 90% effectiveness is as good as it gets, and bodes well for other vaccines. But getting ...
Posted by Michael Wonder on 10 Nov 2020
Bayer submits marketing authorization applications for finerenone in the U.S. and the EU for patients with chronic kidney disease and type 2 diabetes
9 November 2020 - Regulatory submissions based on positive data from Phase 3 FIDELIO-DKD trial recently published in the New England ...
Posted by Michael Wonder on 10 Nov 2020
Mirum Pharmaceuticals broadens Expanded Access Program for maralixibat in Alagille syndrome to Europe and Australia
5 November 2020 - Maralixibat Expanded Access Program now available for patients with pruritus associated with Alagille syndrome in Australia and ...
Posted by Michael Wonder on 10 Nov 2020
Lilly's neutralising antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorisation for the treatment of recently diagnosed COVID-19
9 November 2020 - Bamlanivimab is authorised for treatment of recently diagnosed, mild to moderate COVID-19 in high-risk patients. ...
Posted by Michael Wonder on 10 Nov 2020
Orphazyme submits European Marketing Authorisation application for arimoclomol for treatment of Niemann-Pick disease Type C
9 November 2020 - Follows U.S. FDA acceptance of new drug application with priority review in September 2020. ...
Posted by Michael Wonder on 09 Nov 2020
FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers
9 November 2020 - On 6 November, the FDA approved the FoundationOne Liquid CDx test as a companion diagnostic device to ...
Posted by Michael Wonder on 09 Nov 2020
Impel Neuropharma announces FDA submission of new drug application for INP104 for the acute treatment of migraine
9 November 2020 - The INP104 new drug application is supported by results from the Phase 3 STOP 301 trial. ...
Posted by Michael Wonder on 09 Nov 2020
FDA grants rare paediatric disease designation to AMO Pharma for AMO-02 for treatment of congenital myotonic dystrophy
9 November 2020 - Designation qualifies AMO-02 for fast track review and AMO Pharma to receive a priority review voucher pending ...