Regulatory
The NDA is for a new formulation of the drug as one-dose granules for oral suspension, would which largely be aimed at children and people who have difficulty swallowing.
Although Zeposia has now been approved in the United States, BMS said it was delaying commercialization due to the “unprecedented COVID-19 pandemic.”
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.
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.
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.
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