FDA authorizes Seattle Childrens Therapeutics to launch a CAR T-cell trial to treat lupus in children.
FDA clears a U.S. Army Biotechnology High Performance Computing Software Applications Institute 510(k) for an artificial intelligence-powered smartpho...
FDA grants Lisata Therapeutics an orphan drug designation for LSTA1 and its use in treating osteosarcoma.
Federal Register notice: FDA issues a priority review voucher to Italfarmaco SpA for being the sponsor of a rare pediatric disease product application...
Par Pharmaceutical asks a court to stop FDA from granting final approval to a BPI epinephrine product that cites a Par product as the reference-listed...
FDA asks the Oncologic Drugs Advisory Committee to consider whether minimal residual disease is an appropriate intermediate clinical endpoint to suppo...
A new National Academies report calls on FDA and other federal government entities to take steps to increase the participation of pregnant and lactati...
In the latest move by FDA in its ongoing investigation into the quality of syringes made in China, the agency issues an import alert against Jiangsu S...
