Food and Drug Administration (FDA)
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Research conducted under the collaboration will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns through the use of relevant and new data sources.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 19, 2020.
The approval was based on interim analysis from the company’s Phase III IMpower110 trial.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 18, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 15, 2020.
Following a study that raises concerns about the accuracy of Abbott’s rapid COVID-19 test for detecting the virus, the U.S. Food and Drug Administration (FDA) announced it will investigate the claims found in a New York University-related study as the company updates its guidance on the ID NOW test.
This morning, the companies announced the regulatory agency issued a Refusal to File letter regarding the BLA for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pretreated relapsed and refractory multiple myeloma.
A new report released on Tuesday by GlobalData suggested that there was a 16% decrease in new drug approvals (NDAs) by the U.S. Food and Drug Administration last year.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 12, 2020.
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