Federal Register notice: FDA proposes to require PMAs for spinal spheres for use in intervertebral fusion procedures.
A health and science policy analyst for Citizens Against Government Waste says the Build Back Better act proposed by President Biden will hurt the gen...
Three stakeholders submit comments and questions on a draft International Council on Harmonization guidance on continuous manufacturing.
FDA approves AbbVies JAK inhibitor Rinvoq (upadacitinib; 15 mg, once daily) for treating adults with active psoriatic arthritis who have had an inadeq...
FDA approves a new indication for Bristol-Myers Squibbs Orencia to prevent acute graft versus host disease in combination with immunosuppressants.
FDA approves a Pfizer supplemental NDA for its JAK inhibitor Xeljanz /Xeljanz XR (tofacitinib) for treating adults with active ankylosing spondylitis ...
FDA warns Stanton, CA-based Sanitor about CGMP and other violations in its manufacturing of misbranded unapproved new drugs.
FDA warns Port Washington, NY-based DeVilbiss Healthcare about Quality System regulation violations in the firms manufacturing of oxygen concentrators...