On October 22, 2020, the U.S. Food and Drug Administration (FDA) formally approved Veklury (remdesivir) as a treatment of COVID-19. Veklury, an antiviral drug, is the first treatment approved by FDA to treat COVID-19....more
FDA recently revoked a multi-month Emergency Use Authorization (the EUA) for use of chloroquine and hydroxychloroquine as an experimental treatment for patients suffering from COVID-19. ...more
The U.S. Food and Drug Administration has permitted limited use of the antimalarial drugs hydroxychloroquine and chloroquine in the treatment of COVID-19 since issuing an Emergency Use Authorization for such drugs on March...more
Convalescent blood plasma from patients who have recovered from COVID-19 is a potential treatment that has gained scientific interest. Because COVID-19 convalescent plasma has not yet been approved by FDA, it is regulated as...more
The US Food and Drug Administration (FDA) is prioritizing the development and review of new therapies to treat COVID-19 through a recently created special emergency program titled Coronavirus Treatment Acceleration Program...more
4/10/2020
/ Applicable Manufacturers ,
Biologics ,
Breakthrough Therapy Designation ,
Coronavirus Treatment Acceleration Program (CTAP) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Intellectual Property Protection ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Starting in February 2020, the US Food and Drug Administration (the “FDA”) began using its Emergency Use Authorization (“EUA”) powers under Section 564 of the Federal Food, Drug, and Cosmetic Act (“FD&C”) to allow unapproved...more
4/2/2020
/ 3D Printing ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs