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RSS FeedPosted by Michael Wonder on 06 Apr 2020
Bill Gates to spend billions on coronavirus vaccine development
5 April 2020 - Foundation to help build factories for the seven makers of the most-promising efforts. ...
Posted by Michael Wonder on 06 Apr 2020
India has cut off half the supply of a potential coronavirus treatment touted by Trump
6 April 2020 - Nearly half the supply of hydroxychloroquine to the U.S. comes from makers in India, a flow ...
Posted by Michael Wonder on 06 Apr 2020
Trump pushed health officials to make anti-malaria drugs available as coronavirus treatment: report
4 April 2020 - President Trump pushed health health officials to make anti-malaria drugs available to treat the coronavirus although ...
Posted by Michael Wonder on 05 Apr 2020
Why FDA’s issuance of EUAs are not ‘approvals’ and why that matters
3 April 2020 - You may have read that some drugs are now “approved” to treat COVID-19, or as the ...
Posted by Michael Wonder on 04 Apr 2020
IVERIC bio announces fast track designation from U.S. FDA for Zimura for the treatment of geographic atrophy secondary to dry age-related macular degeneration
3 April 2020 - IVERIC bio announced today that the U.S. FDA has granted fast track designation to Zimura (avacincaptad ...
Posted by Michael Wonder on 03 Apr 2020
U.S. FDA approves Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent, to treat anaemia in adults with lower-risk myelodysplastic syndromes
3 April 2020 - The FDA approval marks the second indication for Reblozyl and the first new treatment option in ...
Posted by Michael Wonder on 03 Apr 2020
Zealand Pharma submits new drug application to the U.S. FDA for the dasiglucagon HypoPal Rescue Pen for treatment of severe hypoglycemia
31 March 2020 - The dasiglucagon HypoPal Rescue Pen new drug application represents a major milestone in Zealand Pharma’s efforts to ...
Posted by Michael Wonder on 02 Apr 2020
Biosimilars could disappear if the Supreme Court overturns the ACA
1 April 2020 - With the sense of urgency rightly focused on slowing or stopping the spread of COVID-19, it ...
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
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
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 ...