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...
Ongoing FDA safety concerns with JAK inhibitors lead to review extensions for Eli Lilly/Incyte and Pfizer submissions.
Members of the FDA Circulatory Systems Device Advisory Panel vote to support the benefits, efficacy, and safety of the TransMedics OCS heart system fo...