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 Lincolnwood, IL-based Dental Technologies about CGMP and QS regulation violations at its contract drug and medical device manufacturing faci...
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...
A California federal judge says a state law banning pay-for-delay generic drug agreements likely violates out-of-state commerce protections.