Food and Drug Administration (FDA)
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A summary of daily biopharma industry news. Please check out stories that are trending on March 26, 2020.
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.
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.
A summary of daily biopharma industry news. Please check out stories that are trending on March 25, 2020.
The ointment had previously been approved for patients ages two and above in 2016.
A summary of daily biopharma industry news. Please check out stories that are trending on March 24, 2020.
The U.S. Food and Drug Administration issued a Completed Response Letter of Eli Lilly and Company and Boehringer Ingelheim’s Jardiance (empaglifozin) for type 1 diabetes.
Priority Review for BLA submission was granted by U.S. FDA for tafasitamab in combination with lenalidomide for relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL) based on positive primary analysis data of L-MIND and Re-MIND studies
The U.S. Food and Drug Administration has a busy week of possible drug approvals on its calendar. Here’s a look.
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