Approvals

A summary of daily biopharma industry news. Please check out stories that are trending on March 26, 2020.
FDA
A day after it was announced remdesivir had received Orphan Drug designation for treatment of COVID-19 from the U.S. Food and Drug Administration, Gilead Sciences submitted a request for the regulatory agency to rescind that offer after an outcry was raised over the potential for exclusivity for the experimental pandemic treatment.
FDA
The same day that New York Gov. Andrew Cuomo announced the initiation of a clinical trial using blood plasma from patients who have recovered from COVID-19, the U.S. Food and Drug Administration announced wider support for the practice.
FDA
PerkinElmer is the 16th company to receive an EUA for COVID-19 testing.
A summary of daily biopharma industry news. Please check out stories that are trending on March 25, 2020.
FDA
The ointment had previously been approved for patients ages two and above in 2016.
FDA
The U.S. Food and Drug Administration has a busy week of possible drug approvals on its calendar. Here’s a look.
FDA
The recommended dose of the drug for this age group is based on weight and liver function.
FDA
The U.S. Food and Drug Administration approved Abbott’s molecular test for the novel coronavirus that causes COVID-19 under an Emergency Use Authorization.
FDA
The U.S. Food and Drug Administration granted Eli Lilly and Company and Incyte Corporation Breakthrough Therapy designation for baricitinib for alopecia areata.
PRESS RELEASES
FDA