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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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Coronavirus Treatment Acceleration Program

1 April 2020 - FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program.  ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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