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RSS FeedPosted by Michael Wonder on 02 Apr 2020
COVID-19: Australia to get virus ‘miracle drug’ soon
2 April 2020 - Health Minister Greg Hunt has announced he has struck a deal to get a “miracle drug” touted ...
Posted by Michael Wonder on 02 Apr 2020
COVID-19 has changed how the world does science, together
1 April 2020 - Never before, scientists say, have so many of the world’s researchers focused so urgently on a single ...
Posted by Michael Wonder on 02 Apr 2020
Seqirus announces positive CHMP Opinion for its adjuvanted quadrivalent influenza vaccine
31 March 2020 - Seqirus today announced that its adjuvanted quadrivalent influenza vaccine - launching as Fluad Tetra - has received ...
Posted by Michael Wonder on 02 Apr 2020
Diurnal's European marketing authorisation application for Chronocort passes validation stage with EMA
1 April 2020 - European regulatory recommendation for approval targeted for Q1 2021. ...
Posted by Michael Wonder on 02 Apr 2020
Y-mAbs announces submission of naxitamab biologics license application to U.S. FDA
1 April 2020 - Y-mAbs Therapeutics today announced that the Company has completed the submission of its biologics license application under ...
Posted by Michael Wonder on 01 Apr 2020
Coronavirus Treatment Acceleration Program
1 April 2020 - FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program. ...
Posted by Michael Wonder on 01 Apr 2020
FDA approves additional treatment for adults and adolescents with haemophilia A or B and inhibitors
1 April 2020 - The U.S. FDA today approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding ...
Posted by Michael Wonder on 01 Apr 2020
COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes
1 April 2020 - Chloroquine and hydroxychloroquine, two medicines currently authorised for malaria and certain autoimmune diseases, are being investigated ...
Posted by Michael Wonder on 01 Apr 2020
Regulatory information - 1.6% increase in fees from 1 April 2020
1 April 2020 - General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.6% on ...
Posted by Michael Wonder on 01 Apr 2020
Rhythm Pharmaceuticals completes rolling submission of new drug application to U.S. FDA for setmelanotide in POMC and LEPR deficiency obesities
30 March 2020 - Rhythm Pharmaceuticals today announced that it has completed its rolling submission of a new drug application to ...
Posted by Michael Wonder on 01 Apr 2020
Aveo Oncology announces submission of new drug application to U.S. FDA for tivozanib in patients with relapsed or refractory renal cell carcinoma
31 March 2020 - Aveo Oncology today announced that it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 01 Apr 2020
GW Pharmaceuticals and Greenwich Biosciences announce FDA acceptance of sNDA filing with priority review for Epidiolex (cannabidiol) in the treatment of seizures associated with tuberous sclerosis complex
31 March 2020 - GW Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently ...
Posted by Michael Wonder on 01 Apr 2020
FDA accepts Mesoblast's biologics licence application for Ryoncil and agrees to priority review
1 April 2020 - Mesoblast today announced that the United States FDA has accepted for priority review the Company’s biologics license ...
Posted by Michael Wonder on 01 Apr 2020
COVID-19 update: FDA continues to accelerate development of novel therapies for COVID-19
31 March 2020 - As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the ...
Posted by Michael Wonder on 01 Apr 2020
MEI Pharma announces fast track designation granted by U.S. FDA for ME-401 for the treatment of adult patients with relapsed or refractory follicular lymphoma
31 March 2020 - MEI Pharma today announced that the U.S. FDA granted fast track designation to ME-401, MEI's investigational selective ...