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.
Federal Register notice: FDA seeks comments on an information collection revision entitled Expanded Access to Investigational Drugs for Treatment Use....
FDA commissioner nominee Robert Califf says, if confirmed, he is going to be very aggressive on curbing social media medical misinformation.