Food and Drug Administration (FDA)
NEWS
The U.S. FDA came out to warn health care personnel not to make any changes to the dosing of the vaccines and that doing so would place the public health at risk and undermine “the historic vaccination effort to protect the population.”
Pfizer and OPKO Health are one step closer to receiving approval for their jointly developed pediatric growth hormone deficiency drug, somatrogon, after the U.S. FDA recently accepted the companies’ regulatory submission for the therapy.
Without an approval for liso-cel, Bristol Myers Squibb said the CVRs have now been terminated, are no longer eligible for payment and will no longer be allowed to trade on the New York Stock Exchange.
The agency placed the hold on the Astellas company’s trial after two patients died in the trial.
In October, the FDA placed a clinical hold on the company’s Huntington’s disease gene therapy before that asset could make its way into the clinic.
The U.S. Food and Drug Administration has approved several drugs and medical devices in the last week. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 22, 2020.
Myovant’s oral Orgovyx beat out Abbvie’s injectable Lupron in achieving medical castration levels in patients. Here is the timeline of the approval.
The company and Operation Warp Speed began distribution of the vaccine through McKesson, along with United Parcel Services and FedEx, over the weekend. The first vaccinations are expected today.
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