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...
FDA recommends that ERC-USA and the University of California, Irvine, pursue a confirmatory Phase 3 registration trial for ERC 1671, a cell-based immu...
FDA approves Bausch + Lombs ClearVisc dispersive ophthalmic viscosurgical device (OVD) for use in ophthalmic surgery.
CDRH posts two new training modules for aspects of the Medical Device Single Audit Program.
AbbVie submits a supplemental BLA for Skyrizi (risankizumab-rzaa) 150 mg for treating adults with active psoriatic arthritis.
WuXi Biologics says it passed two FDA inspections at its facility in China, perhaps signaling an increase in agency foreign inspections after a long p...