FDA
The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.
FEATURED STORIES
After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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Abbott’s new point-of-care test for the novel coronavirus that causes COVID-19 was approved by the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA).
A summary of daily biopharma industry news. Please check out stories that are trending on March 27, 2020.
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.
The U.S. Food and Drug Administration has a busy week of possible drug approvals on its calendar. Here’s a look.