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RSS FeedPosted 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 ...
Posted by Michael Wonder on 09 Nov 2020
Novavax COVID-19 vaccine granted fast track designation by U.S. FDA
9 November 2020 - Novavax today announced that the U.S. FDA has granted fast track designation for NVX-CoV2373, the Company’s COVID-19 ...
Posted by Michael Wonder on 09 Nov 2020
Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia
9 November 2020 - Calquence demonstrated superior progression-free survival and favourable tolerability in both previously untreated and relapsed or refractory ...
Posted by Michael Wonder on 09 Nov 2020
Liminal BioSciences announces FDA extension of review period for Ryplazim (plasminogen) BLA
9 November 2020 - PDUFA date extended by FDA from 5 March 2021 to 5 June 2021. ...
Posted by Michael Wonder on 09 Nov 2020
FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults
6 November 2020 - Today, the U.S. FDA permitted marketing of a new device intended for the temporary reduction of sleep ...
Posted by Michael Wonder on 09 Nov 2020
AFT welcomes US FDA complete response letter
9 November 2020 - AFT Pharmaceuticals today announces it has received a US FDA complete response letter covering its application ...
Posted by Michael Wonder on 09 Nov 2020
Makena indication may fall based on post-approval data
6 November 2020 - The US FDA is seeking to withdraw the approval of the only drug indicated to prevent ...
Posted by Michael Wonder on 08 Nov 2020
Made in Melbourne: lab to start producing promising coronavirus vaccine
8 November 2020 - Global biotech company CSL will begin manufacturing millions of vials of one of the most promising ...
Posted by Michael Wonder on 07 Nov 2020
Ligand's partner Sedor Pharmaceuticals receives FDA approval for Sesquient for the treatment of status epilepticus in adult and paediatric patients
6 November 2020 - Captisol enabled product is stable at room temperature for timely administration at the point of patient care. ...