FDA approves UCBs Cimiza for treating adults with non-radiographic axial spondyloarthritis, with objective signs of inflammation.
New York attorney general Letitia James files suit against six opioid manufacturers, the Sackler family, and four opioid distributors over their roles...
FDA clears a Hitachi Chemical Diagnostics 510(k) for its new high capacity allergy testing instrument, Optigen AP 3600.
FDA commissioner Scott Gottlieb says the agency should have a new way of approving new opioid drug submissions that considers them in a different clas...
FDA grants Imbrium Therapeutics an orphan drug designation for its investigational drug EDO-S101 (tinostamustine), a potentially first-in-class therap...
FDA approves a Novartis NDA for Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis.
FDA issues a guidance to help applicants know where to place pediatric information in labeling for prescription drug and biological products.
DC federal court chief judge says both FDA and the Judge Rotenberng Educational Center have not fully met their responsibilities under the Freedom of ...