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RSS FeedPosted by Michael Wonder on 28 May 2020
Tax payers paid to develop remdesivir but will have no say when Gilead sets the price
27 May 2020 - Critics say government deserves more credit for tens of millions in public money spent to develop coronavirus ...
Posted by Michael Wonder on 27 May 2020
FDA grants priority review of Nucala for patients with hypereosinophilic syndrome
27 May 2020 - An approval would give Nucala a third indication in an eosinophil driven disease. ...
Posted by Michael Wonder on 27 May 2020
U.S. FDA approves Opdivo (nivolumab) and Yervoy (ipilimumab) combined with limited chemotherapy as first-line treatment of metastatic or recurrent non-small cell lung cancer
26 May 2020 - Approval marks sixth indication for Opdivo and Yervoy-based combinations across five types of cancer. ...
Posted by Michael Wonder on 27 May 2020
Cellectar receives FDA fast track designation for CLR 131 in lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinaemia
26 May 2020 - Cellectar Biosciences today announced the U.S. FDA has granted fast track designation for CLR 131 in lymphoplasmacytic ...
Posted by Michael Wonder on 27 May 2020
FDA approves first treatment for a form of bladder dysfunction in paediatric patients as young as 2 years of age
26 May 2020 - The U.S. FDA today granted approval to VESIcare LS (solifenacin succinate) oral suspension for the treatment of ...
Posted 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 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. ...