Government
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 FDA put a clinical hold on UniQure’s Phase III trial after a high-risk participant developed liver cancer.
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.
The U.S. FDA is plenty busy with COVID-19 vaccine Emergency Use Authorizations this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Here’s a look.
The U.S. Food and Drug Administration (FDA) had several approvals this week. Read on to see what the regulatory agency gave the go-ahead to.
Applications include a nasal COVID-19 vaccine, an NSCLC drug, respiratory infection drug and a treatment for a chronic inflammation of the esophagus.
A critical vote is set to take place today amongst those on a U.S. Food and Drug Administration advisory panel in regard to the COVID-19 vaccine from Moderna.
The U.S. Food and Drug Administration has authorized the first non-prescription, over-the-counter, at-home antigen test that can be used to identify infection with SARS-CoV-2, the virus responsible for COVID-19, in people two years of age or older.
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