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RSS FeedPosted 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 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
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
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. ...
Posted by Michael Wonder on 24 May 2020
Federal scientists finally publish remdesivir data
23 May 2020 - A clinical trial led to the authorisation of the only drug shown to work in COVID-19 patients. ...
Posted by Michael Wonder on 24 May 2020
FDA shuffles longtime division head, Janet Woodcock, to focus exclusively on COVID-19 vaccine project
22 May 2020 - FDA stalwart Janet Woodcock will temporarily step aside as the director of the agency’s Center for ...
Posted by Michael Wonder on 24 May 2020
Hikma receives FDA approval for its generic Vascepa
22 May 2020 - Hikma Pharmaceuticals today announces that its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received ...
Posted by Michael Wonder on 24 May 2020
Zealand Pharma announces FDA acceptance of new drug application for the dasiglucagon HypoPal rescue pen for treatment of severe hypoglycemia
22 May 2020 - PDUFA target action date scheduled for 27 March 2021. ...
Posted by Michael Wonder on 23 May 2020
U.S. FDA approves Takeda’s Alunbrig (brigatinib) as a first-line treatment option for patients diagnosed with rare and serious form of lung cance
22 May 2020 - Long-term results from the Phase 3 ALTA 1L trial established Alunbrig as a superior first-line treatment compared ...
Posted by Michael Wonder on 23 May 2020
Intercept provides regulatory update
22 May 2020 - Intercept Pharmaceuticals today announced that based on discussions earlier this week, the U.S. FDA has notified Intercept ...