Government
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.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 14, 2020.
Following the announcement that Slaoui was tapped to helm Operation Warp Speed, Jim Greenwood, president and CEO of BIO, hailed that decision.
The designation will expedite regulatory review of the medication should it prove to be safe and effective.
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.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 13, 2020.
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.
The government has added additional charges of conspiracy, wire fraud, and forfeiture.
Approval of Abbott’s latest antibody test comes days after the FDA tightened its rules regarding the regulatory requirement for them.
The Lynparza approval isn’t as broad as the Zejula approval, with Lynparza not approved for use in patients with homologous recombination deficiencies.
PRESS RELEASES