The American Society of Health-System Pharmacists says drug shortages are at the highest level since 2001.
During a 4/11 hearing , U.S. Representative Ro Khanna (D-CA) criticizes FDA and commissioner Robert Califf for not doing enough to prevent frivolous p...
A federal appeals court affirms a lower court decision barring FDA from approving a Norwich ANDA for a generic form of Salix Xifaxan until 10/2/2029.
Two stakeholders comment positively on an FDA public meeting on advancing the use of complex innovative designs in clinical trials.
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...
