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RSS FeedPosted by Michael Wonder on 27 May 2020
FDA approves only drug in U.S. to treat severe malaria
26 May 2020 - Today, the U.S. FDA approved artesunate for injection to treat severe malaria in adult and paediatric patients. ...
Posted by Michael Wonder on 26 May 2020
FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis
26 May 2020 - In the pivotal trial, more than twice as many children achieved clear or almost clear skin and ...
Posted by Michael Wonder on 26 May 2020
Aurinia completes submission of new drug application to the U.S. FDA for voclosporin for the treatment of lupus nephritis
26 May 2020 - Application supported by extensive global clinical program including the pivotal Phase 3 AURORA study and the ...
Posted by Michael Wonder on 26 May 2020
Kala Pharmaceuticals announces FDA acceptance of new drug application for Eysuvis for dry eye disease
26 May 2020 - FDA sets PDUFA goal date of 30 October 2020. ...
Posted by Michael Wonder on 26 May 2020
Protara Therapeutics receives fast track designation from U.S. FDA for intravenous choline chloride for the treatment of intestinal failure associated liver disease
26 May 2020 - Protara Therapeutics today announced that the U.S. FDA has granted fast track designation to intravenous choline chloride ...
Posted by Michael Wonder on 26 May 2020
EMA calls for high-quality observational research in context of COVID-19
26 May 2020 - For observational studies of real world data in COVID-19, EMA calls for transparency for protocols and results, ...
Posted by Michael Wonder on 26 May 2020
Australians stick with malaria drug hydroxychoroquine trial
26 May 2020 - Australian researchers are pressing ahead with administering the controversial antimalarial drug hydroxychloroquine in at least one ...
Posted by Michael Wonder on 26 May 2020
Ofev (nintedanib) now available in Canada for adults living with progressive fibrosing interstitial lung diseases
25 May 2020 - Ofev slowed lung function decline in PF-ILD patients by 57% compared to placebo. ...
Posted by Michael Wonder on 25 May 2020
First generic version of Gilead’s remdesivir will be sold by a Bangladesh drug maker
22 May 2020 - A drug maker in Bangladesh has become the first company to sell a generic version of ...
Posted by Michael Wonder on 25 May 2020
Inside the science: companies racing to develop a COVID-19 vaccine
25 May 2020 - Even as some states move to ease the lockdowns that have cost tens of millions of ...
Posted by Michael Wonder on 25 May 2020
WHO pauses trial of hydroxychloroquine in COVID-19 patients due to safety concerns
26 May 2020 - The World Health Organisation has suspended testing the malaria drug hydroxychloroquine in COVID-19 patients due to ...
Posted by Michael Wonder on 25 May 2020
TGA approves Rozlytrek
25 May 2020 - Roche secures TGA approval for another cancer medicine. ...
Posted by Michael Wonder on 25 May 2020
How the world’s premier public health agency was handcuffed
23 May 2020 - The CDC has been absent with leave during the spread of COVID-19. ...
Posted by Michael Wonder on 24 May 2020
Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by EMA
22 May 2020 - Fresenius Kabi announced today that the EMA has accepted for review the company’s marketing authorisation application for ...
Posted by Michael Wonder on 24 May 2020
U.S. is ahead of China in vaccine race, former FDA chief says
24 May 2020 - Data on Chinese vaccines in clinical development “didn’t look overwhelmingly strong,” Scott Gottlieb said. ...