FDA grants Gilead Sciences full approval for Trodelvy (sacituzumab govitecan-hziy) for certain adult patients with unresectable locally advanced or me...
FDA posts a five-observation Form FDA-483 from a 4/2020 inspection at troubled contract manufacturer Emergent Biosolutions Baltimore manufacturing fac...
CBER publishes its annual fiscal year summary of biological product and HCT/P deviation reports.
FDA warns Allure Imports that it is marketing unapproved and misbranded drugs for use in humans or animals for Covid-19 indications.
National Institute on Aging researchers say they are evaluating whether drugs FDA approved for other indications could be repurposed to be used agains...
Attorney Andrew Tauber says a New Jersey federal court reiterated that plaintiffs in medical device manufacturing defect cases cannot infer a defect s...
Two Mintz attorneys see the potential for congressional hearings into FDAs handling of a Team Biologics whistleblower complaint alleging improprieties...