Blog
RSS FeedPosted 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 ...
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 ...