FDA solicits comments on software functions excluded from the medical device definition by the 21st Century Cures Act.
FDA publishes a guidance on the content and format of patient instructions for use documents for prescription drugs and biologics.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Genentechs Enspryng (satralizumab-mwge).
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Blenrep (belantamab mafodotin-...
Summit Therapeutics says it is considering whether to hold at least one more clinical trial of its C. Diff treatment radinilazole as discussed at a me...
Teva asks the Supreme Court to hear its appeal of an Appeals Court decision invalidating its skinny label on a generic version of GlaxoSmithKlines Cor...
FDA clears a Medtronic 510(k) for its UNiD Spine Analyzer v4.0 planning platform, which includes a new Degen Algorithm for degenerative spine procedur...
FDA gives 510(k) clearance to the Onkos Surgical 3D personalized pelvic reconstruction system.