Government
Eli Lilly is seeking Emergency Use Authorization for its antibody therapy, LY-CoV555, for the treatment of high-risk patients with recently diagnosed mild-to-moderate coronavirus disease 2019 (COVID-19).
The new guidelines posted Tuesday by the FDA, call for vaccine developers to follow patients dosed with the experimental medication for at least two months before seeking Emergency Use Authorization.
In his resignation, Bright said that the Trump administration “ignores scientific expertise, overrules public health guidance and disrespects career scientists.”
Makena, the only FDA-approved treatment to reduce preterm birth failed to meet endpoints in a recent trial. The FDA gave notice of intent to withdraw approval.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 6, 2020.
The sticking point for the White House is a provision in the guidance that calls for vaccine manufacturers to follow people participating in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot.
The new high-speed test uses a high-throughput method comprising heat and technology to extract RNA from samples used for COVID-19 RT-PCR molecular testing.
Although October doesn’t appear to be a very busy month for the U.S. Food and Drug Administration’s PDUFA dates, there are a few. Here’s a look at the next two weeks.
At 74 years old, Trump is in a category of older Americans who are at more vulnerable to infection, and at higher risk of developing more serious symptoms.
In mid-August, the FDA’s Oncologic Drugs Advisory Committee voted 9 to 1 to recommend the drug for that indication. Although the agency isn’t required to follow an advisory committee’s recommendation, it usually does.
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