Regulatory
The agency placed the hold on the Astellas company’s trial after two patients died in the trial.
The United Kingdom is expected to give the green light to the vaccine developed by AstraZeneca and Oxford University this week.
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.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 29, 2020.
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 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.
It seems like history is repeating itself from just a week ago. Yesterday, the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the agency grant Moderna’s COVID-19 vaccine emergency use authorization (EUA).
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